Boston Scientific Associate Quality Director 

Ireland, Cork 

256173247

Advancing possibilities for a brighter tomorrow

We are seeking an Associate Director of Quality & Qualified Person on a

Job Purpose:

The purpose of the Associate Director of Quality and QP role is to provide quality, and compliance expertise to ensure that all pharmaceutical products manufactured and distributed by the organization meet the highest standards of quality, safety, and regulatory compliance. Key responsibilities include to provide subject matter expertise, provide functional leadership, including allocating and managing department resources to accomplish business objectives, to ensure compliance of quality system activities and objectives, and to interface with external regulatory agencies. This role is essential in overseeing and managing Boston Scientific Cork’s Pharmaceutical Quality Management System (PQS) and ensuring that the products comply with industry regulations. This role will support the site QP and serve as a backup QP to ensure that pharmaceutical products are properly reviewed, and their release is compliant with regulatory standards.

Key Responsibilities:

• • Talent Management: Recruit, coach, and develop organizational talent. Foster a diverse workplace that enables all participants to contribute to their full potential.
  • Leadership: Lead the Pharmaceutical Quality team, ensuring team members have the necessary training, skills and knowledge to effectively meet the quality requirements as detailed in regulatory standards, and drive process optimization initiatives. Provide direction and guidance to the wider team, fostering a culture of excellence, collaboration, and continuous improvement.
  • Pharmaceutical Quality System: Act as Pharmaceutical Head of Quality. Applies and leverages a comprehensive knowledge of pharmaceutical quality systems that ensure the highest quality products and compliance with GMP Guidance and regulatory requirements. Review and analyze the effectiveness of the quality system and recommend changes as needed.
  • Regulatory Compliance: Ensure efficient compliance with all applicable regulations through a robust quality system and communication with regulatory authorities. Sets best practices and influences compliance with policies and procedures
  • Operational Management:Ensure that all necessary preparations are made for both internal and external audits and regulatory inspections. Lead audit teams, collaborate with cross-functional teams to address and resolve any observations or deficiencies, ensuring continuous compliance with applicable regulations and quality standards. Responsible for the leadership of the Quality Operations team supporting chemistry based products.
  • Crisis Management: Leads complex analysis of data and decisions regarding quality-related crises in the their area of responsibility.
  • Continuous Improvement: Foster an entrepreneurial environment where individuals identify and bring forward process, policy, and system improvements to the Pharmaceutical Quality System (PQS).
  • New Product Introduction (NPI): Collaborate with the NPI team to ensure product designs, formulations, and processes comply with cGMP standards and regulatory expectations.

Education & Experience:

• • Level 8 in Science or Engineering (Level 9 desirable)
  • 10+ years of experience in pharmaceutical/biotech manufacturing, particularly in Quality Assurance (QA), Quality Control (QC), or Compliance.
  • 5+ years in a leadership or managerial quality-related role.
  • Strong understanding of cGMP, ICH guidelines, EU GMP Annexes, and FDA/HPRA expectations.
  • Experience with regulatory inspections (e.g., HPRA, FDA).
  • Medical Device manufacturing experience desirable.
  • Established experience in leading and solving complex problems.
  • Experience as QP preferrable.

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