Associate Director Global Pharmacovigilance Quality Management
Associate Director Global Pharmacovigilance Quality Management
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$ 156000 - 195000
1 Vacancy
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 limbgirdle 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.
Were 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 worklife 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: Importance of the Role
This position facilitates quality planning regulatory compliance and continuous improvement of Sareptas pharmacovigilance (PV) processes and systems across Sareptas investigational and marketed products and partner/vendor collaborations. This position requires a learning agile and experienced professional with strong systemsthinking problemsolving and decisionmaking 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 crossfunctional projects utilizing industrystandard 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 selfinspection 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 incountry 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 systemsthinking 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
- Working knowledge and understanding of global regulations for safety and pharmacovigilance including FDA EMA and ICH guidelines preferred
- Exhibits attributes congruent 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
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Exec
Employment Type
Full-Time
