Position Overview
The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Company’s Research Laboratories Division is seeking an Associate Director for the GxP compliance and documentation team. The role will be based at the Schachen, Switzerland research facility and will drive a culture of quality and operational excellence across a global analytical network. Key Responsibilities
Manage a team of metrology and validation specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP environment. Oversee 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. Contribute to SOPs related to metrology and validation. Conduct audit and inspection activities for analytical groups at the Schachen site, including preparation, support during audits/inspections, and managing observation responses and CAPAs. Perform internal compliance walkthroughs and data integrity deep‑dive activities for laboratory functions at the Schachen site. Qualifications
Effective leadership skills to enable identification and implementation of innovative improvement strategies supporting the development pipeline across modalities. Ability to function independently and collaborate in a fast‑paced, integrated, multidisciplinary team environment. Strong organizational and project management skills, effective multi‑tasking, and written and oral communication skills. Background of delivering innovative solutions to complex problems with a global mindset to drive cross‑functional collaboration. Education and Experience
Minimum: B.S. with 10+ years, M.S. with 7+ years, or Ph.D. with 3+ years of relevant experience. Minimum 5 years of experience in pharmaceutical or related industry supporting GMP analytical laboratory testing or QA for laboratory areas. In‑depth knowledge of ICH requirements, the Eudralex, PICS, and other governing regulations. Experience leading a team and working both independently and in cross‑functional settings. Demonstrated initiative, innovative problem‑solving, and willingness to learn new concepts outside core expertise. Excellent oral and written communication, creativity, and interpersonal skills. Preferred Experience
Experience authoring SOPs for GMP analytical laboratories. Experience supporting GMP documentation and training within the pharmaceutical industry. Instrument commissioning, qualification, and validation (CQV) experience. Experience in instrument computer system validation. Demonstrated commitment to inclusion. Other Information
The company is an equal opportunity employer that ensures a diverse and inclusive workplace.
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The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Company’s Research Laboratories Division is seeking an Associate Director for the GxP compliance and documentation team. The role will be based at the Schachen, Switzerland research facility and will drive a culture of quality and operational excellence across a global analytical network. Key Responsibilities
Manage a team of metrology and validation specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP environment. Oversee 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. Contribute to SOPs related to metrology and validation. Conduct audit and inspection activities for analytical groups at the Schachen site, including preparation, support during audits/inspections, and managing observation responses and CAPAs. Perform internal compliance walkthroughs and data integrity deep‑dive activities for laboratory functions at the Schachen site. Qualifications
Effective leadership skills to enable identification and implementation of innovative improvement strategies supporting the development pipeline across modalities. Ability to function independently and collaborate in a fast‑paced, integrated, multidisciplinary team environment. Strong organizational and project management skills, effective multi‑tasking, and written and oral communication skills. Background of delivering innovative solutions to complex problems with a global mindset to drive cross‑functional collaboration. Education and Experience
Minimum: B.S. with 10+ years, M.S. with 7+ years, or Ph.D. with 3+ years of relevant experience. Minimum 5 years of experience in pharmaceutical or related industry supporting GMP analytical laboratory testing or QA for laboratory areas. In‑depth knowledge of ICH requirements, the Eudralex, PICS, and other governing regulations. Experience leading a team and working both independently and in cross‑functional settings. Demonstrated initiative, innovative problem‑solving, and willingness to learn new concepts outside core expertise. Excellent oral and written communication, creativity, and interpersonal skills. Preferred Experience
Experience authoring SOPs for GMP analytical laboratories. Experience supporting GMP documentation and training within the pharmaceutical industry. Instrument commissioning, qualification, and validation (CQV) experience. Experience in instrument computer system validation. Demonstrated commitment to inclusion. Other Information
The company is an equal opportunity employer that ensures a diverse and inclusive workplace.
#J-18808-Ljbffr
Associate Director, Lead of Laboratory Compliance, Metrology, and Validation (m/f/d) Arbeitgeber: MSD Malaysia
MSD Malaysia bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Zusammenarbeit und Innovation ausgerichtet ist. Als Strategic Market Access Director für Impfstoffe in der EUCAN-Region haben Sie die Möglichkeit, bedeutende Strategien zu entwickeln und die Gesundheitsversorgung aktiv zu gestalten. Das Unternehmen fördert kontinuierliches Lernen und berufliche Weiterentwicklung, während es gleichzeitig ein starkes Engagement für Vielfalt und Inklusion zeigt.
