Mgr Quality Assurance

Description

The role is Manager Quality Assurance for Operational Commercial Products, a people leadership position in the Quality function at the Leiden site in South Holland, Netherlands.

The company develops and manufactures innovative medicines for patients worldwide. Around 2,000 people work at the site.

The site's QA group gives independent GMP oversight across manufacturing, laboratories, the warehouse, maintenance and quality-system activities.

You will sit on the QA-OCP management team and work closely with Operations, the warehouse, QC labs, maintenance and MSAT. The role combines people leadership, operational quality oversight, stakeholder management and digital quality governance.

Responsibilities

• Lead, coach and grow a team of 8 to 12 QA specialists.
• Act as the main QA contact for Operations, Warehouse, QC Laboratories, Maintenance and MSAT.
• Own the handling and escalation of complex quality and compliance problems.
• Keep GMP processes for commercial manufacturing and testing current and improving.
• Provide quality oversight and governance for digital and computerized systems, including ERP, MES, business intelligence tools, computerized system validation and qualification.
• Prepare the site for inspections and manage the process during regulatory inspections.

Requirements

• A master's degree in a relevant scientific or technical field, such as biosciences, pharmacy, analytical chemistry, process technology or engineering.
• At least six years in quality or a similar GMP setting at a pharmaceutical, consumer or medical device company, including at least two years in a people leadership role.
• A quality-first outlook, sound risk-based judgment, and the ability to make quality decisions and defend them.
• Working knowledge of quality management principles, cGMP, and quality system rules for pharma (ICH, FDA and EMA).
• Understanding of digitalization, business intelligence, ERP and MES systems, and computerized system validation and qualification.
• Perfect written and spoken Dutch and English.
• Comfortable working as a team member and taking a firm position when needed.
• Understanding of AI concepts and frameworks, including responsible and ethical AI use, and experience writing effective prompts to improve efficiency and productivity.
• Preferred, not required: experience with compliance management, CAPA, cross-functional collaboration, developing others, fact-based decision making, giving feedback, GMP, inclusive leadership, ISO 9001, leadership, quality control (QC), QMS, quality standards, quality validation, risk assessments, SOPs, tactical thinking and team management.

Conditions

Full-time employment based in Leiden, South Holland, Netherlands.

Anticipated base pay range is €68 600,00 to €119 600,00.

The company treats each employee as an individual and respects diversity and dignity.

Benefits

• An annual bonus with a set target percentage of pay, set by pay grade and location, paid on the performance of the company and the employee in the previous calendar year, or sales commissions.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave and volunteer leave.
• Well-being reimbursement and programs for financial, physical and mental health.
• Service anniversary and recognition awards.
• Insurance plans, subject to plan terms, with eligible dependents able to join in some locations.
• Flexible working arrangements.
• A place within a global market leader.
• A dynamic working environment.
• The chance to set up and lead a new team within the Quality organization.
• Exposure to current and future biopharmaceutical manufacturing technologies.
• Access to an international network of quality and digital-system experts.
• Continuous professional development.
• Amounts and benefits may vary by location and may change, so this information is for guidance only.