Associate Director/ESQL

Job Description

Permanent contract is possible

Associate Director/ESQL

Purpose of the role

You are responsible for implementing Quality Operations (QA/QC) policies and ensuring compliance with external partners (EPs) involved in the manufacturing, testing, packaging, storage, and distribution of API and intermediates. You ensure that all products are manufactured using approved processes and meet regulatory and company standards, potentially including product release. You play a leadership role in monitoring compliance with GMP, ICH, FDA, and other regulatory requirements. Responsibilities include direct oversight of external partners, providing technical guidance to senior site leadership, and supporting partner selection, GMP due diligence, and Quality Agreement setup. You also support building robust quality systems and driving continuous improvement initiatives at partner sites.

Main responsibilities

• Ensures the EP’s Quality Operations comply with company policies and global GMP/regulatory requirements.
• Develops and maintains Quality Agreements with external partners and contributes to commercial contract terms related to quality.
• Implements a calibrated quality oversight program, based on product type, EP capabilities, and compliance performance.
• Responsible for product release (e.g., API intermediates), ensuring conformance to specifications, approved processes, and regulatory requirements.
• Provides direct QA/QC support to EPs, including oversight of product testing, batch documentation review, and deviation investigations.
• Maintains and oversees supplier performance management, including regulatory inspections, complaint handling, feedback, and annual product reviews.
• Reviews audit outcomes and ensure timely corrective and preventive actions at EP sites.
• Monitors and drives continuous improvement in EP quality and reliability through regular oversight and formal communication forums.
• Supports new product introductions, including compliance input, analytical/process implementation, and inspection readiness.
• Prepares and supports content for Quality Council meetings, including minutes and presentations.
• Coordinates or supports significant investigations (e.g., Fact Findings) and product recalls.
• Ensure compliance with corporate Safety and Health Policy in all activities.
• Conducts due diligence and pre-approval assessments for new external partners and supports gap remediation.
• May act as regulatory liaison with authorities on behalf of the company regarding external partner activities.
• Collaborates cross-functionally to align EP oversight with broader business and operational objectives.

Your profile

• Bachelor’s or master’s degree in science, Engineering, or another relevant technical discipline (e.g. Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent).
• Prior experience in the pharmaceutical industry.
• Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.
• Solid understanding of global GMP standards and regulatory compliance requirements.
• Prior experience in API manufacturing and/or external manufacturing support (preferred).
• Experience managing and supporting Quality Operations involving external parties (e.g. contract manufacturers, testing labs, distribution partners).
• Strong analytical and scientific problem-solving skills, with ability to assess complex product, production, or testing issues.
• Broad knowledge of manufacturing operations, external supplier management, and supply chain processes and project management.
• Conversant with regulations and compendia governing pharmaceutical operations.
• Some levels of contractual and financial awareness.
• Demonstrated ability to work independently, with guidance required only in highly complex situations.
• Proactive in internal or external business and compliance issues identifying and recommending process or product improvements.
• Strong verbal and written communication skills in English.
• Demonstrated personal networking and relationship-building skills.
• Ability to make sound decisions in an ambiguous or rapidly changing environment.
• Lean Six Sigma or continuous improvement experience (preferred).
• Willingness and ability to travel up to 25% of the time, including on short notice.

What we offer

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

• Competitive salary and a 3% year-end bonus.
• 35,5 days of leave.
• Attractive collective health care insurance package.
• Solid Pension Plan.
• Incentive Plan (bonus).
• Commuting allowance.
• Parental leave for both parents.
• Numerous training, coaching, and e-learning modules for long term job opportunities and development.

Secondary Job Description

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.

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:

No relocation

VISA Sponsorship:

No

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

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R534462