Associate Director, Lead of Laboratory Compliance, Metrology, and Validation (m/f/d)

Job Description

The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Company`s Research Laboratories Division is seeking applicants for an Associate Director position in the GxP compliance and documentation team to support the global analytical organization. The position will be based at the Schachen, Switzerland research facility. 

The Compliance Associate Director will work as part of the integrated Compliance team and be pivotal in driving a culture of quality and operational excellence across a global analytical network.  The key responsibilities of this role include:

• Manage a team of metrology and validation specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP environment.

• Management and oversight of Good Manufacturing Practices (GMP) documentation, training, and standard operating procedures (SOPs) for the global network.

• Originate and own investigations and change records related to laboratory instruments

• Drive harmonization of analytical procedures across the global network. Manage and contribute to SOPs related to metrology and validation.  

• Audit and inspection activities for analytical groups at the Schachen site, including preparation efforts, support during audits/inspections, and managing observation responses and CAPAs. 

• Internal compliance walkthroughs and data integrity deep dive activities for the laboratory functions at the Schachen site. 

Experience supporting laboratory audits and inspections is a required skill.  The qualified candidate must possess effective leadership skills to enable the identification and implementation of innovative strategies for improvement to support the development pipeline across modalities – biologics, small molecules, and vaccines.

The successful candidate must be able to function independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  We are looking for a team player with a passion for GMP compliance, strong organizational and project management skills, effective multi-tasking ability, and effective communication skills, both written and oral. Applicants must demonstrate a background of delivering innovative solutions to complex problems with a global mindset to drive cross-functional collaboration.

Education Minimum Requirements (standard for each level)

B.S. with 10+ yrs, M.S. with 7+ yrs, or Ph.D. with 3+ yrs of relevant experience.            

Required Experience and Skills

• Bachelor’s degree, or higher, in analytical chemistry or related field

• Minimum 5 years of experience in pharmaceutical or related industry supporting GMP analytical laboratory testing or as quality assurance for laboratory areas.

• In-depth knowledge of ICH requirements, the Eudralex, PICS, and other governing regulations.

• Experience leading a team.

• An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives.

• Demonstrated ability for taking initiative and innovative problem solving

• Desire and ability to learn new concepts outside of core expertise and training

• Excellent oral and written communication skills, demonstrated creativity, and effective interpersonal skills.

• Experience working within a GMP environment.

• Desire and ability to learn new concepts outside of core expertise and training

Preferred Experience and Skills

While not required, experience in one or more of the following areas is beneficial.

• Demonstrated commitment to inclusion.

• Experience authoring SOPs for GMP analytical laboratories.

• Experience supporting GMP documentation and training within the pharmaceutical industry.

• Experience in Instrument commissioning, qualification, and validation (CQV)

• Experience in instrument computer system validation

Learn more about us: Analytical Research & Development (AR&D)

The Company

Our Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence».  

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Required Skills:

Biopharmaceuticals, Cross-Functional Collaboration, FDA Inspections, GMP Compliance, Good Manufacturing Practices (GMP), Inspection Readiness, Internal Compliance, Lab Equipment Maintenance, Laboratory Techniques, Laboratory Testing, People Leadership, Process Improvements, Team Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. 

Employee Status:

Regular

Relocation:

International

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/19/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.