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

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