Senior Director, Corporate Quality – PV

Sarepta Therapeutics•Bedford, MA

1d•Hybrid

About The Position

The Sr. Director, Corporate Quality, Pharmacovigilance will be responsible for 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.

Requirements

Bachelor’s degree in Life Sciences with 15 years in pharmaceutical or biotech drug development.
Minimum 10 years of experience in GCP/GVP QA, with at least 5 years of focused GVP QA experience
Demonstrated experience working with clinical trial teams
Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
Previous experience facilitating and/or supporting Regulatory Authority Inspections
Direct experience in development and oversight of Quality Management Systems
Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross functional personnel at all levels
Strong technical writing skills. Ability to write briefing documents, quality positions, investigations, audit reports and SOPs.
Good understanding of the drug development processes, clinical operations, regulatory affairs and GVP auditing
Knowledge of regulatory guidelines in different geographic regions
Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems
Strong judgment and decision-making skills
General project management skills
Candidates must be authorized to work in the U.S.

Nice To Haves

Advanced degree preferred.

Responsibilities

Participate in the development of the internal and external Corporate Quality 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
Design the long-term audit strategy for GVP-related audits to meet applicable regulatory requirements.
Oversee 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
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.
Participate in inspection readiness and preparedness activities and support regulatory inspections