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4D Molecular Therapeutics designs, develops and commercializes transformative gene therapeutic products for serious unmet medical conditions.

4D Molecular Therapeutics Icon

4D Molecular Therapeutics (4DMT) is a clinical-stage biopharmaceutical company that is dedicated to inventing and developing innovative products in the field of genetic medicine. Their goal is to unlock the full potential of genetic medicine to treat a wide range of large market diseases. The company utilizes a transformative vector discovery platform called Therapeutic Vector Evolution, which enables them to create customized and proprietary gene delivery vehicles (vectors) for targeted delivery of therapeutic payloads to specific tissue types associated with the underlying disease. With a focus on bold innovation, 4DMT's product design, development, and manufacturing engine allows them to efficiently create a diverse product pipeline. They are committed to revolutionizing genetic medicines and strive towards developing potential curative therapies. Guided by their core principles of daring to cure, breaking boundaries, achieving beyond oneself, and relentless preparation and execution, 4DMT is led by a team of experienced and visionary leaders from various disciplines. The company is driven by their unwavering dedication to improving patient lives and realizing the full potential of genetic medicine.

4D Molecular Therapeutics

4D Molecular Therapeutics Logo

4D Molecular Therapeutics (4DMT) is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

4DMT is taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. The company's people are the essence of an inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. 4DMT is centered on core values that direct every facet of work, culture, hiring and drive to scale the world-class genetic medicines company.

4DMT champions diversity, equity and inclusion every single day. Employee-led Diversity efforts are inspired by guiding principles to focus awareness on social equity and create positive change not only within 4DMT, but in the community at large. The company seeks to embrace patient populations to help raise awareness and has partnered with charitable organizations including food banks, reading partners, and biotech industry groups.

4DMT is focused on hiring, inspiring and supporting the best people in the industry who identify with the company's vision. The company creates an exciting, dynamic and collaborative environment that fosters dedication to visionary science and medicine, recognizes performance, offers generous benefits and provides challenging opportunities for career development.

## Senior Manager, Audit and Supplier Management (Contract)

**Location:** Remote, United States

**Reporting:** Director, Quality Systems

**GENERAL SUMMARY:**

This position reports to the Director, Quality Systems and contributes to the development, implementation, and successful execution of 4DMT's Quality Assurance and Compliance mission, objectives, and strategic plan by overseeing 4DMT's GxP Compliance Audit and Supplier Quality Management Programs.

**MAJOR DUTIES & RESPONSIBILITIES:**

The Sr. Manager, Audit and Supplier Management, will be responsible for the operational management of 4DMT's GxP Compliance Audit and Supplier Quality Management Programs, ensuring audits are managed and documented and Suppliers assessed and qualified according to 4DMT procedures. Specific responsibilities include:

**Audit Program:**

- Coordinate and manage clinical site, internal, and vendor audits by working with Quality Assurance, Functional Area Management, and Contract auditors to facilitate scheduling, planning, tracking, documentation, and closure of audits
- Perform detailed review of audit deliverables to ensure accuracy, consistency with 4DMT standards, and compliance with GxP regulations.
- Track and facilitate timely and compliant finalization of key Audit deliverables such as Audit Confirmation Letters, Audit Reports, Audit Observation Responses, and Audit Certificates by responsible parties
- Ensure audit deliverables are reviewed, distributed, and archived in alignment with 4DMT procedural requirements.
- Schedule pre/post-audit meetings with auditors and key stakeholders
- Collaborate with relevant 4DMT team members to ensure auditors have required system access / documentation in support of audits.
- Work with Quality Assurance Management to establish and periodically update risk-based Annual Audit Schedule
- Coordinate with stakeholders to ensure the Annual Audit Schedule is executed, including the scheduling of GxP audits for clinical sites, internal 4DMT systems / processes, and vendors / suppliers such as contract manufacturers, testing laboratories, and clinical research organizations.
- Collaborate with QA Auditors to ensure responses to significant audit observations include adequate Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs), as applicable.
- Monitor, track, and collect/archive evidence of completion of Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs) for significant audit observations, when required.
- Ensure QA Auditors are qualified and trained per 4DMT procedures

**Supplier Quality Management Program:**

- Ensure 4DMT's Approved GxP Supplier List is accurate and complete by working with stakeholders to support timely identification, assessment, qualification, and periodic re-assessment of GxP Suppliers
- Coordinate and manage the completion of supplier risk assessments
- Ensure appropriate supplier evaluation / qualification requirements are identified based on risk, communicated as appropriate, and executed
- Support compliance with 4DMT's Supplier Quality Management procedure

**General:**

- Develop excellent working relationships with the quality team, cross-functional business partners, vendors, and other functions
- Develop and report meaningful audit and supplier quality metrics for Quality Assurance Management Review reporting
- Support a quality-focused work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork
- Drive the development and continuous improvement of the Quality Management System through the development / refinement of QA processes / initiatives as assigned

**QUALIFICATIONS:**

**Education:**

- B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.

**Experience:**

- 8+ years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar industry. Minimum of 3+ years of experience in a role including responsibility for providing GxP QA oversight

**Other Qualifications/Skills:**

- Proven experience with GxP Quality Management Systems and QA audit support, including knowledge of quality investigation / root cause analysis techniques
- In-depth understanding of GMP and GCP requirements for investigational products
- Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life cycle
- Excellent communication skills, both oral and written
- Excellent interpersonal skills, collaborative approach is essential
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

**Travel:** 5%

**Physical Requirements and Working Conditions:**

- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

**Compensation:**

Hourly compensation range: $75.00 – $86.00/hr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.

Executive HR leader in Biotech | People-First, Science-Driven | Investor in Women-Led Startups to Drive Inclusive Venture Capital

Jelica Stulic

Senior Vice President, Human Resources

Senior Recruiter / Talent Acquisition Partner | Full-Cycle Recruiting & Strategic Sourcing | Biotech, Tech & High-Growth Teams

Elizabeth Santamaria

Sr. Recruiter

Strategic HR Leader | Fostering High-Performing Teams in Biotech

Joey Perez

Senior Director, Total Rewards & HR Operations

Senior Manager, HR Operations and Systems

Senior Manager, Audit and Supplier Management (Contract)

Chief Audit Executive

Quality Management Systems

Supplier Management

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our 4 Guiding Principles drive the way we work together: 
-	Dare to Cure
-	Break Boundaries 
-	Beyond Yourself 
-	Prepare & Execute Relentlessly 

Join us in creating the future of genetic medicine.


***Attention recruitment agencies:*** *All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.*

  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

**GENERAL SUMMARY:**

This position reports to the Director, Quality Systems and contributes to the development, implementation, and successful execution of 4DMT's Quality Assurance and Compliance mission, objectives, and strategic plan by overseeing 4DMT's GxP Compliance Audit and Supplier Quality Management Programs.

**MAJOR DUTIES & RESPONSIBILITIES:**

The Sr. Manager, Audit and Supplier Management, will be responsible for the operational management of 4DMT's GxP Compliance Audit and Supplier Quality Management Programs, ensuring audits are managed and documented and Suppliers assessed and qualified according to 4DMT procedures. Specific responsibilities include:

Audit Program:

- Coordinate and manage clinical site, internal, and vendor audits by working with Quality Assurance, Functional Area Management, and Contract auditors to facilitate scheduling, planning, tracking, documentation, and closure of audits
- Perform detailed review of audit deliverables to ensure accuracy, consistency with 4DMT standards, and compliance with GxP regulations.
- Track and facilitate timely and compliant finalization of key Audit deliverables such as Audit Confirmation Letters, Audit Reports, Audit Observation Responses, and Audit Certificates by responsible parties
- Ensure audit deliverables are reviewed, distributed, and archived in alignment with 4DMT procedural requirements.
- Schedule pre/post-audit meetings with auditors and key stakeholders
- Collaborate with relevant 4DMT team members to ensure auditors have required system access / documentation in support of audits.
- Work with Quality Assurance Management to establish and periodically update risk-based Annual Audit Schedule
- Coordinate with stakeholders to ensure the Annual Audit Schedule is executed, including the scheduling of GxP audits for clinical sites, internal 4DMT systems / processes, and vendors / suppliers such as contract manufacturers, testing laboratories, and clinical research organizations.
- Collaborate with QA Auditors to ensure responses to significant audit observations include adequate Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs), as applicable.
- Monitor, track, and collect/archive evidence of completion of Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs) for significant audit observations, when required.
- Ensure QA Auditors are qualified and trained per 4DMT procedures

Supplier Quality Management Program:

- Ensure 4DMT's Approved GxP Supplier List is accurate and complete by working with stakeholders to support timely identification, assessment, qualification, and periodic re-assessment of GxP Suppliers
- Coordinate and manage the completion of supplier risk assessments
- Ensure appropriate supplier evaluation / qualification requirements are identified based on risk, communicated as appropriate, and executed
- Support compliance with 4DMT's Supplier Quality Management procedure

General

- Develop excellent working relationships with the quality team, cross-functional business partners, vendors, and other functions
- Develop and report meaningful audit and supplier quality metrics for Quality Assurance Management Review reporting
- Support a quality-focused work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork:
- Drive the development and continuous improvement of the Quality Management System through the development / refinement of QA processes / initiatives as assigned

**QUALIFICATIONS:**

Education:

- B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.

Experience:

- 8+ years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar industry. Minimum of 3+ years of experience in a role including responsibility for providing GxP QA oversight

Other Qualifications/Skills:

- Proven experience with GxP Quality Management Systems and QA audit support, including knowledge of quality investigation / root cause analysis techniques
- In-depth understanding of GMP and GCP requirements for investigational products
- Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life cycle
- Excellent communication skills, both oral and written
- Excellent interpersonal skills, collaborative approach is essential
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Travel: 5%

Physical Requirements and Working Conditions:

- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Hourly compensation range: $75.00 – 86.00/hr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Emeryville

This role involves managing 4DMT's GxP Compliance Audit and Supplier Quality Management Programs, ensuring audits are managed and documented, and suppliers are assessed and qualified according to procedures.

4D Molecular Therapeutics

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Senior Manager, Audit and Supplier Management

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