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At Boston Scientific, we offer opportunities to work with diverse, high-performing teams tackling significant health industry challenges. With access to the latest tools, training, and information, we support your career development and ambitions.
Advancing possibilities for a brighter tomorrow
We are seeking an Associate Director of Quality & Qualified Person on a permanent basis to join our team.
Job Purpose
The Associate Director of Quality and QP provides expertise in quality and compliance to ensure pharmaceutical products meet high standards of quality, safety, and regulatory compliance. Responsibilities include providing subject matter expertise, leading departmental resources, ensuring quality system compliance, and interfacing with regulatory agencies. This role oversees Boston Scientific Cork’s Pharmaceutical Quality Management System (PQS), ensuring product compliance and supporting the site QP, serving as a backup QP for product review and release.
Key Responsibilities
* Talent Management: Recruit, coach, and develop talent, fostering a diverse workplace where all can contribute fully.
* Leadership: Lead the Pharmaceutical Quality team, ensuring training and skills development, driving process improvements, and fostering a culture of excellence and collaboration.
* Pharmaceutical Quality System: Act as Pharmaceutical Head of Quality, applying knowledge of quality systems to ensure product quality and compliance with GMP and regulations, reviewing their effectiveness.
* Regulatory Compliance: Ensure compliance with regulations through a robust quality system and communication with authorities, setting best practices.
* Operational Management: Prepare for audits and inspections, lead audit teams, address observations, and oversee Quality Operations supporting chemistry-based products.
* Crisis Management: Lead analysis and decision-making during quality crises.
* Continuous Improvement: Promote process and system improvements within the PQS.
* New Product Introduction: Collaborate with NPI teams to ensure product designs and processes meet cGMP and regulatory standards.
Education & Experience
* Level 8 in Science or Engineering (Level 9 preferred)
* 10+ years in pharmaceutical/biotech manufacturing, especially QA, QC, or Compliance
* 5+ years in leadership roles
* Deep understanding of cGMP, ICH, EU GMP, FDA/HPRA standards
* Experience with regulatory inspections (e.g., HPRA, FDA)
* Medical Device manufacturing experience is desirable
* Proven problem-solving experience
* Experience as QP is advantageous
At Boston Scientific, we are committed to solving health challenges and transforming lives through innovative medical solutions. We value diversity and inclusion, believing it fosters innovation and reflects the communities we serve. We are an equal opportunity employer and support reasonable accommodations for applicants with disabilities.
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