Associate Director, Quality Compliance

Job Description

Site Lead Auditor; leiding geven aan site auditing team en aan supplier quality team. Zie verder job description SLA.

Secondary Job Description

For our manufacturing site in Oss, the Netherlands, we are currently looking for an:

Associate Director, Quality Compliance (Site Quality Lead)

The Position:

The Associate Director, Quality Compliance leads the Audit & Supplier Quality Management team (5-7 people) to ensure compliance with cGMP, regulatory and QMS requirements across Organon in our Oss manufacturing site. At the same time, the Associate Director, Quality Compliance ensures the effectiveness and efficiency of the supplier quality management and auditing site programs.

Key Responsibilities:

Take proactive leadership to create (by leading, development, coaching and mentoring) a team that has the ability and willingness to advocate for compliance towards internal and external quality standards.

Inspection Readiness:

• Enhance and maintain Permanent Inspection Readiness status.
• Identify regulatory changes in inspection approaches.

Internal Audits and External Inspections & Audits:

• Lead site internal audit program, covering end-to-end, system based and Walk Through audits.
• Lead Health Authority inspections, notified body audits, customer audits and Global GMP audits.
• Review and approve audit reports, CAPA responses, and monitor completion.
• Perform internal and for-cause audits and participate in opportunities to audit other Organon sites.
• Generate annual audit schedules and performance reports.
• Promote a quality compliance culture and audit program performance.

Supplier Quality Management:

• Ensure supplier qualification and manage quality agreements.
• Oversee supplier change control and complaints processes.
• Analyze and improve supplier quality performance.

Quality Management System:

• Provide Topic Lead for Auditing and External Network.
• Participate in relevant Communities of Practice and External Network Quality Council.

Training:

• Train, qualify and mentor auditors and supplier quality officers.
• Ensure auditors have up-to-date technical and compliance skills.

Continuous Improvement:

• Lead and support improvements in auditing and supplier quality processes.
• Track and report metrics for supplier quality, audits, and inspections.

Contacts:

Site Leadership Team, Production, COE’s, Global Quality Systems & Compliance, Supplier Development and Performance Management, Health Authorities, Notified Bodies and suppliers.

Profile:

• Master's degree in a relevant scientific discipline
• Minimum 5 years of relevant experience in the pharmaceutical industry
• Proficiency in GMP compliance and regulatory requirements
• Knowledge of Quality Systems in a GMP environment
• Strong leadership, team-building and mentoring abilities
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders and influence across disciplines and all levels
• Ability and willingness to advocate for compliance position with management using objective evidence
• Excellent organizational and communication skills in Dutch and English

Preferred experience:

• GMP audits, leading effective audits and hosting Health Authority inspections
• Expertise in medical devices, combination products, and drug products

We offer:

We welcome you to a truly global, dynamic, and challenging environment with excellent personal development opportunities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Travel allowance for commuting;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .

Search Firm Representatives Please Read Carefully
Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

No Travel Required

Flexible Work Arrangements:

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R528009