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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we offer the opportunity to work with diverse, high-performing teams to address key challenges in the healthcare industry. With access to advanced tools, information, and training, we support your skill and career development, fostering progress regardless of your 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 all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and regulatory compliance. Key responsibilities include providing subject matter expertise, leading departmental resources, ensuring compliance with quality systems, and liaising with regulatory agencies. This role oversees Boston Scientific Cork’s Pharmaceutical Quality Management System (PQS), ensuring product compliance with industry regulations. It also supports the site QP and acts as a backup QP for product review and regulatory compliance during product release.
Key Responsibilities:
1. Talent Management: Recruit, coach, and develop talent. Promote a diverse workplace that enables full contribution from all participants.
2. Leadership: Lead the Pharmaceutical Quality team, ensuring team members are trained and skilled to meet regulatory standards, and drive process improvements. Provide strategic direction, fostering a culture of excellence, collaboration, and continuous improvement.
3. Pharmaceutical Quality System: Serve as Pharmaceutical Head of Quality, applying comprehensive knowledge of pharmaceutical quality systems to ensure product quality and compliance with GMP and regulatory standards. Review and improve the effectiveness of quality systems.
4. Regulatory Compliance: Maintain efficient compliance with regulations through a robust quality system, liaising with regulatory authorities, and promoting best practices.
5. Operational Management: Prepare for and lead internal and external audits and inspections. Collaborate with cross-functional teams to address observations, ensuring continuous compliance. Lead the Quality Operations team supporting chemistry-based products.
6. Crisis Management: Lead complex data analysis and decision-making regarding quality-related crises.
7. Continuous Improvement: Foster an entrepreneurial environment where team members identify and implement process, policy, and system improvements within the PQS.
8. New Product Introduction (NPI): Collaborate with NPI teams to ensure product designs, formulations, and processes meet cGMP standards and regulatory expectations.
Education & Experience:
* Level 8 in Science or Engineering (Level 9 preferred)
* 10+ years in pharmaceutical/biotech manufacturing, especially in QA, QC, or Compliance
* 5+ years in leadership or managerial quality roles
* Strong knowledge of cGMP, ICH guidelines, EU GMP Annexes, and FDA/HPRA standards
* Experience with regulatory inspections (e.g., HPRA, FDA)
* Proven ability to lead and resolve complex problems
* Experience as QP is preferable
As a leader in medical science for over 40 years, Boston Scientific is committed to solving critical health challenges. Our mission to advance science for life aims to transform lives through innovative medical solutions that improve patient outcomes, create value, and support our communities. We believe in fostering a diverse and inclusive workplace, which is essential for innovation and excellence. We are proud to be an equal opportunity employer and provide reasonable accommodations for applicants with disabilities. For accommodations during recruitment, please contact TalentAcquisitionIre@bsci.com.
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Job Segment: Biology, Biotech, QA, QC, Quality Assurance, Science, Technology, Quality
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