Associate Director, Global Pharmacovigilance Quality Management

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:

• 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. This position 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 continuously improving Sarepta PV processes and systems.
• Collaborate with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, etc. in establishing and continuously improving Sarepta processes.
• Manage cross-functional projects utilizing industry-standard project management methods.
• Monitor GPV and vendor PV compliance against applicable plans, standard operating procedures, contracts, regulations and guidelines.
• Establish PV operating policies and procedures aligning with governing regulations, departments, and partnering functions. (Includes mapping of new and existing PV processes using MS Visio.)
• Lead the implementation and maintenance of a comprehensive PV training program. Develop and deliver training curricula and content to internal and external Sarepta stakeholders.
• Implement and oversee PV Agreements for vendors, distributors, and license partners.
• Monitor Key Performance Indicators and metrics. Coordinate collation of data for management reports and score cards.
• Lead the PV deviation/CAPA program and manage deviations and CAPAs related to PV, inclusive of internal and vendor origin.
• Maintain a PV self-inspection program ensuring constant inspection readiness.
• Manage the audit/inspection backroom and represent PV in audits and inspections, including direct interactions with auditors and inspectors.
• Support patient access and market expansion through implementation and maintenance of local and global in-country safety reporting compliance.
• Consult, review, and approve PV and stakeholder procedures, documents, records, contracts, Pharmacovigilance and Safety Data Exchange Agreements, program and study plans, and other material with PV impact.

More about You

• Advanced degree in Sciences, Engineering, Nursing, or Healthcare Administration
• Minimum 8 - 10 years’ experience in Quality Management or related professional experience
• Demonstrated systems-thinking, strategic planning, and quality management skills with attention to detail
• Proven ability to build relationships and influence across disciplines and all levels
• Experience leading continuous improvement initiatives
• Excellent written and verbal communication skills
• Proficient with MS Office and Visio
• Experience with QMS, audit and inspection management, document and training management, CAPA and project management
• Work