Associate Director, Pharmacovigilance Quality Assurance

Sarepta Therapeutics, Inc.; Cambridge (MA); Hybrid; USD 156,000 - 195,000; Full time

Job summary

An established industry player is seeking an Associate Director for R&CD QA Pharmacovigilance. This pivotal role involves overseeing GVP quality and audit programs, ensuring compliance and readiness for inspections. The ideal candidate will thrive in a hybrid work environment, balancing on-site collaboration with remote flexibility. Join a company that values innovation and integrity, where your contributions will directly impact the lives of patients. If you are a solution-oriented thinker with a passion for quality assurance in the life sciences, this opportunity is for you.

Benefits

Comprehensive benefits package

Support for caregivers

Financial wellness programs

Physical and emotional wellness resources

Qualifications

• Experience in pharmacovigilance and quality assurance in the biotech or pharmaceutical industry.
• Strong understanding of regulatory requirements and audit processes.

Responsibilities

• Support GVP quality oversight and manage audit programs.
• Collaborate with stakeholders to ensure compliance and audit execution.
• Develop and review SOPs and assist in inspection readiness.

Skills

Pharmacovigilance

Quality Assurance

Regulatory Compliance

Audit Management

Risk Management

Critical Thinking

Education

Bachelor's Degree in Life Sciences

Advanced Degree (Master's or PhD)

Tools

SOPs

Audit Reports

Job description

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

1. Physical and Emotional Wellness
2. Financial Wellness
3. Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role
The Associate Director, R&CD QA Pharmacovigilance, with minimal supervision, will support the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.

This position will participate in inspection readiness activities and audits, as appropriate. This position will have direct reports and report to the Director, Research & Clinical Development Quality Assurance (R&CD QA).

The Opportunity to Make a Difference

1. Participate in the development of the internal and external R&CD QA annual audit plan for GVP, REMS, PV vendors, interfaces, processes and preferred business partners and update the audit plan as needed based on identified risks and priorities.
2. Provide oversight and support to global Pharmacovigilance (PV) function to identify risks and risk mitigation strategies.
3. Support the existing long-term audit strategy for GVP-related audits to meet applicable regulatory requirements.
4. Support the timely development and distribution of audit reports and follow up actions.
5. Collaborate with key stakeholders to ensure audit plan execution.
6. Ensure the corrective and preventive actions are appropriately identified and completed in a timely manner.
7. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.
8. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior management.
9. Work collaboratively to perform investigations to identify root cause of compliance issues and provide appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management.
10. Develop and/or review SOPs, Policies, documents etc., as needed.
11. Serve in an advisory/consultative role in compliance related matters for pharmacovigilance and support the internal team in evaluating metrics and trending exercises and/or identifying implementing corrective and preventive actions.
12. Participate in inspection readiness and preparedness activities and support regulatory inspections.

More about You

as above

What Now?
We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.