As a member of the Quality Leadership Team, the Director, Quality Assurance will oversee the strategic and operational deliverables for the Quality Assurance group as they pertain to international product supply and country launches. As a strategic leader, he/she will ensure a quality assurance approach to assessing data and problem solving within the international Good Manufacturing Practices (GMP)/ Good Distribution Practices (GDP) environment. More specifically, the Director will work closely with the domestic Quality team and other regional direct reports (Responsible Persons -RPs, Qualified Persons -QPs) as well as other groups to ensure successful delivery on short- and long-term Quality goals and objectives, while ensuring product supply while expanding into new markets and aligning operational functions to meet the business needs. Through knowledge and hands-on experience with international (EU, LATAM, Asia Pacific) cGMP and GDP manufacturing/distribution arena with Contract Manufacturing and third party distribution partners, he/she will lead, design, develop, implement and manage the quality systems to ensure the safety, efficacy, purity, and compliant storage and distribution of Sarepta products. The Quality Director will also oversee international compliance requirements and documentation.
Primary Responsibilities Include:
- Provide direction and leadership to quality assurance management to ensure that the quality of the supply/cold chain and integrity of our products and services are achieved, maintained, and improved
- Provide direction and leadership to regional quality personnel to ensure that products are legally registered in the applicable countries prior to distribution
- Direct the creation, approval, and maintenance of wholesale distribution submissions / registrations documentation and risk management documentation, ensure appropriate licensure of Sarepta products
- Ensure compliance to all relevant US and international regulations / laws as relevant to regulatory affairs, design assurance, and risk management. Educate management and teams as needed.
- Participate and support in FDA, EMA, notified body, supplier and/or other inspections / audits including internal activities
- Facilitate communications with external agencies and internal teams
- Interface with distribution partners and 3PLs across multiple locations, develop and maintain Quality Agreements and provide oversight of their Quality programs and systems, recommending and implementing improvements and efficiencies as appropriate
- Drive the development and documentation of Global, Domestic, Regional Quality procedures, policies, protocols and standards to support GMP/GDP activities partner withinternal groups such as QA Compliance, GDP and GMP activities. Document Control, and Quality Operations and others as assigned, ensuring team’s successful delivery and achievement of business goals
- Ensure GMP/GDP compliance with regulatory requirements across all areas, working withCMOs and other vendors as appropriate to ensure a high standard of product quality for patients
- Oversee Quality Events, such as document control, and product release, change control procedures, deviations, CAPA, and ensure effectiveness and compliance
- Drive internal activities to support compliance and “inspection readiness” in close collaboration with Regulatory Affairs, Technical Operations, and other stakeholders
- Guide, mentor and coach staff and managers, promoting skills development and career growth
Education and Skills Requirements:
- BS in Biomedical Sciences or related field; advanced degreepreferred
- 12+ years of leadership experience within Pharmaceutical Quality, inclusive of experienceworking with regulatory authorities, including the FDA, EMA, ANVISA, TGA and PMDA.
- Strong leadership and communication skills; ability to communicate with regulatory agencies as needed
- Strong and clear understanding of cGMPs, GDPs and international standards
- Comprehensive understanding of international GMP/GDP regulations, guidelines and compliance requirements
- Proven track record of successful leadership, strength of character and ability to articulate and defend business approaches
- Demonstrated exercise of sound judgment, discretion, and business decisions; creative approach to problem solving
- Ability to work collaboratively and effectively with internal and external teams and to build relationships in a dynamic and complex environment
- Self-driven, motivated and results-oriented
- Proficient technical skills
- Excellent verbal, written, interpersonal relations and partnering skills.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
- Travel: Willingness to travelinternationally up to 20% of time for at least the first year of employment; thereafter, travel as necessary.