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Associate Director QA + GMP 
Location: Amsterdam
Start: September 2021 (flexible)


Place in the Organization

The Associate Director of GMP QA will lead the AMS GMP Quality staff to provide required oversite to GMP activities on site.  As the most senior Quality operation on site, the individual will represent Quality at the site management team and will be contact person for all external regulatory agency interaction in relation to GMP site activities.  The Associate Director will be responsible to manage a staff to support day-to-day GMP operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, and data integrity in support of biologics manufacturing production including oversight of on site Quality Control.  Additional responsibilities include supporting/conducting internal audits and will lead all regulatory agency or third-party inspections.

 

Key result areas (major duties, accountabilities and responsibilities) 

  • Manage a team of 5-6 Quality professionals either as individual contributors or people managers
  • Support cGMP Manufacturing, Engineering, Validation, Supply Chain, and QC laboratory operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Responsible for tracking and trending QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
  • Be main contact person for local and international Regulatory Agencies and manage these relationships effectively.
  • Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release, as necessary.
  • Conduct/assist in internal audits against applicable quality system standards and regulations.
  • Lead and host any regulatory agency or third-part inspections.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.
  • Main Quality contact for site leadership team
  • Mentor junior QA staff.

 

Qualifications

  • Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
  • 15+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
  • Proof of managing a staff of more than 5 people
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
  • Internal and/or external audit and Regulatory inspection experience required.

 

Core competencies

  • Strong communication skills
  • Strong organizational skill
  • Detail oriented
  • Good problem-solving skills
  • Capable of working with minimal supervision
  • Ability to work well with diverse groups
  • Ability to multi-task in a fast-paced environment with changing priorities

 

Qualifications

  • Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
  • 10+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
  • Position requires incumbent to be able to demonstrate ability to gown aseptically.

 

Core competencies

  • Strong communication skills
  • Strong organizational skill
  • Detail oriented
  • Good problem-solving skills
  • Capable of working with minimal supervision
  • Ability to work well with diverse groups
  • Ability to multi-task in a fast-paced environment with changing priorities

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804