Associate Director, Pharmacovigilance Quality Assurance

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

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

• 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 

• Provide oversight and support to global Pharmacovigilance (PV) function to identify risks and risk mitigation strategies  

• Support the existing long-term audit strategy for GVP-related audits to meet applicable regulatory requirements. 

• Support the timely development and distribution of audit reports and follow up actions 

• Collaborate with key stakeholders to ensure audit plan execution. 

• Ensure the corrective and preventive actions are appropriately identified and completed in a timely manner. 

• Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. 

• As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior management. 

• 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. 

• Develop and/or review SOPs, Policies, documents etc., as needed