The Sarepta Therapeutics Quality Assurance Unit is seeking to fill a permanent full-time position for a Manager, Global eQMS & Administration, assuming responsibilities associated with performing various quality system/business administration activities in support of Sarepta’s Global GxP Quality Management System (QMS).
The successful candidate will have experience working within a regulated pharmaceutical/biotech environment and will be expected to interact with personnel across all levels and functional areas within the company. The position will encompass multiple tasks, including but not limited to, maintaining / co-administering compliant GxP Quality Systems (Document Control, Training LMS, Change Control, CAPA, Deviations, Investigations, Risk Management & Complaint Handling) in accordance with US and International guidelines and regulatory requirements.
This role will work closely with the QA Compliance - Quality Systems Team, GxP business stakeholders, and IT technical teams to assure sustained compliance across Sarepta’s QMS.
This position reports to the Sr. Manager, Global GxP Quality Systems. Primary responsibilities will include the following:
- Adhere to Sarepta’s QMS Policies and procedures to ensure continued compliance.
- Partake and co-manage system improvements, which include performing configuration, testing, data migration, and additional tasks associated with transitioning into a new enhanced eQMS system (Veeva).
- Perform business administration tasks within Sarepta’s eQMS by helping to assess potential functionality enhancements; apply risk mitigation strategies; and manage system upgrades 3x per year.
- In conjunction with QS Staff, develop and provide end user support across all Sarepta sites; serve as an eQMS Subject Matter Expert (SME) and provide daily end user support.
- Assess incoming requests/feedback from our user community and partner with IT to ensure any identified technical issues are addressed in a timely manner.
- Act as a change agent when eQMS improvements are made, driving communication and cross collaboration across GxP functional areas.
- Revise procedures and documentation as system changes occur; assist with any training/retraining tasks, as assigned within area of expertise.
- Collect and report on critical KPI metrics; manage process and monthly/quarterly reporting to drive effectiveness and continuous improvement.
- Perform user account maintenance activities in support ofvarious employee onboarding, change management, and offboarding needs.
- Provide inspection readiness support during internal audits and regulatory inspections (remote/on-site, as needed).
- Evaluate system records and data in support of data governance measures to assure users are utilizing the system as expected.
- Complete cross functional training and provide backup support to other team members, as assigned.
Education and Skills Requirements:
- BA/BS degree in a related field or equivalent experience.
- 6+ years related eQMS work experience within a regulated industry environment.
- Vast experience managing Veeva QDocs, Training and QMS Vaults required; advanced Veeva administration and reporting experience a plus.
- Knowledge/experience managing Veeva’s security model.
- Experience upgrading, configuring, and testing electronic QMS processes required.
- Use of risk management principles and tools as it relates to CSV validation required.
- Advanced Microsoft Excel skills required; additional working knowledge of Power BI a plus.
- Must be flexible, organized, detail-oriented, and able to handle multiple priorities in a fast-paced environment.
- Excellent oral/written communication, problem solving/issue resolution, and prioritization skills.
- Proficiency to understand and translate business requirements to technical teams.
- Ability to work independently and in team environments.
- Strong understanding of global GxP QMS requirements a must.
#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 $112,000 - $140,000 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.