Director Quality Assurance

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Job Description:

Janssen Biologics (JBV) is recruiting for a Director, Quality Assurance, reporting to the Site Quality Head Leiden Biotherapeutics and located in Leiden, the Netherlands.

This position is responsible for leading all Quality Assurance related programs and activities to support the JBV site. These functions and activities include Quality Assurance and product release activities. Ensures that products align with applicable standards and have been manufactured and released according to cGMP. 

Key responsibilities:

• Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release. This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety, quality and regulatory policies and guidelines.
• Leader of QA organisation in technical and personnel aspects, definition of performance goals and employee’s appraisals.
• Ensure inspection readiness and lead Health Authority, regulatory compliance, and customer audits.
• Assures that appropriate metrics/targets are established and met.
• Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.

Provide leadership to direct reports through:

• Developing and championing an organizational culture that promotes behaviours that lead to outstanding business performance and organizational excellence.
• Engages in proactive relationships with the local/regional/national regulatory authority.
• Encourages, supports, and advises initiatives and programs that lead to improved quality and regulatory compliance.
• Leads and guides staff and those involved in quality activities to achieve the best results.
• Mentors and coaches’ staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.

• Advanced degree required or equivalent experience in a scientific or engineering field.

Experience and skills
Required: 

• At least 10 years’ experience in a similar position within the pharmaceutical industry manufacturing biotherapeutics products
• Strong experience in leading a large team in a complex organization, daily, but also through regulatory inspections (e.g. FDA, EMEA etc.).
• Knowledge of, and experience with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals is a must. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Shown success in leading in a global organization
• Fluent knowledge of English language. Dutch knowledge is highly preferred

Preferred:

• Experience on a site manufacturing licence as Qualified Person

Other:

• Gives strategic direction to the Quality groups in the execution of their duties.
• Coordinates the activities of the groups within quality to create a collaborative approach to goals and tasks.
• Through personal expertise, leadership, and dedication, provides direction to the site in the development of a culture of quality and compliance.
• Participates in the overall collective leadership by the senior management team at the site.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.