Associate Director – Global Pharmacovigilance Quality Management

Associate Director – Global Pharmacovigilance Quality Management

Requirements

• 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
• 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

Responsibilities

• 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.

Preferred Qualifications

• Working knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA, and ICH guidelines preferred
• Global experience is preferred