Associate Director, Global Pharmacovigilance Quality Management

Sarepta Therapeutics; City of Rochester (MA, NY); Remote; USD 156,000 - 195,000; Full time

Job summary

An innovative company at the forefront of genetic medicine is seeking a dedicated professional to enhance pharmacovigilance processes. This role offers the chance to lead quality management initiatives and collaborate with diverse teams to ensure compliance and improve systems. With a commitment to patient welfare and a supportive work culture, this position provides a unique opportunity to contribute to life-changing therapies. Join a team that values integrity, kindness, and scientific rigor, and be part of a mission that makes a real difference in patients' lives.

Benefits

Comprehensive benefits

Support for Caregivers

Physical and Emotional Wellness programs

Financial Wellness resources

Qualifications

• 8-10 years of experience in Quality Management or related fields.
• Strong systems-thinking and strategic planning skills.

Responsibilities

• Facilitate PV quality planning and continuous improvement.
• Manage cross-functional projects and monitor compliance.

Skills

Quality Management

Project Management

Communication Skills

Continuous Improvement

Systems Thinking

Education

Advanced degree in Sciences

Healthcare Administration

Tools

MS Office

MS Visio

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 supporting them in all aspects of their lives. We aim to maintain a culture that encourages people to bring their whole selves to work, helping everyone 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:

• Physical and Emotional Wellness

• Financial Wellness

• 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

This position facilitates quality planning, regulatory compliance, and continuous improvement of Sarepta's pharmacovigilance (PV) processes and systems across Sarepta's investigational and marketed products and partner/vendor collaborations. The role requires a learning agile and experienced professional with strong systems-thinking, problem-solving, and decision-making skills. The incumbent will join the Global Pharmacovigilance and Risk Management (GPVRM) department, reporting directly to the Head of Global Pharmacovigilance Quality Management.

The Opportunity to Make a Difference

• Facilitate strategic PV quality planning and identify, analyze, and implement opportunities for continuous improvement of Sarepta PV processes and systems.
• Collaborate with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, etc., to establish and improve Sarepta processes.
• Manage cross-functional projects using industry-standard project management methods.
• Monitor GPV and vendor PV compliance against plans, SOPs, contracts, regulations, and guidelines.
• Establish PV operating policies and procedures aligned with regulations and departmental needs, including mapping PV processes using MS Visio.
• Lead the implementation and maintenance of a PV training program, developing and delivering training content for stakeholders.
• Oversee PV Agreements for vendors, distributors, and license partners.
• Monitor KPIs and metrics, and coordinate data collection for reports and scorecards.
• Lead the PV deviation/CAPA program, managing deviations and CAPAs related to PV, including internal and vendor issues.
• Maintain a PV self-inspection program to ensure inspection readiness.
• Manage audit/inspection processes, representing PV during audits and inspections, including interactions with auditors and inspectors.
• Support patient access and market expansion through compliance with safety reporting requirements.
• Review and approve PV and stakeholder documents, procedures, records, contracts, and other materials impacting PV.

More about You

• Advanced degree in Sciences, Engineering, Nursing, or Healthcare Administration.
• Minimum 8-10 years of experience in Quality Management or related fields.
• Strong systems-thinking, strategic planning, and quality management skills with attention to detail.
• Ability to build relationships and influence across disciplines and levels.
• Experience leading continuous improvement initiatives.
• Excellent communication skills, both written and verbal.
• Proficient with MS Office and Visio.
• Experience with QMS, audits, inspections, document and training management, CAPA, and project management.
• Knowledge of global safety and pharmacovigilance regulations (FDA, EMA, ICH) is preferred.
• Attributes aligned with Sarepta Behaviors: Patient Mission, Scientific Rigor, Simplicity, Bias to Action, One Sarepta, and Trust.
• Global experience is preferred.
• Occasional travel may be required.

What Now?

We're always seeking solution-oriented, critical thinkers. If you're comfortable with ambiguity and candor, enjoy challenging yourself, and value kindness and integrity in your work and interactions, we encourage you to apply.

#LI-Remote #LI-PM1

This position is remote but may require on-site work at one of Sarepta's facilities in the U.S. and attendance at company-sponsored events. The salary range is $156,000 - $195,000 annually, commensurate with experience and other factors. Candidates must be authorized to work in the U.S. Sarepta offers competitive compensation and benefits. We are an Equal Opportunity/Affirmative Action employer and participate in E-Verify.