Position Overview
The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Company’s Research Laboratories Division seeks an Associate Director to lead the GxP compliance and documentation team supporting the global analytical organization. The role is based at our Schachen, Switzerland research facility.
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.
* Initiate and own investigations and change records related to laboratory instruments.
* Drive harmonization of analytical procedures across the global network and contribute to SOPs related to metrology and validation.
* Lead audit and inspection activities for analytical groups at the Schachen site, including preparation, support during audits/inspections, and management of observation responses and CAPAs.
* Conduct internal compliance walkthroughs and data integrity deep‑dive activities for laboratory functions at the Schachen site.
Education Minimum Requirements
* B.S. with 10+ years of relevant experience.
* M.S. with 7+ years of relevant experience.
* Ph.D. with 3+ years of relevant experience.
Required Experience and Skills
* Bachelor’s degree or higher in analytical chemistry or a related field.
* Minimum 5 years of experience in a pharmaceutical or related industry supporting GMP analytical laboratory testing or quality assurance for laboratory areas.
* In‑depth knowledge of ICH regulatory requirements, EudraLex, PICS, and other governing regulations.
* Experience leading a team.
* Effective collaborator with the ability to work both independently and in a cross‑functional team setting.
* Demonstrated ability to take initiative and solve problems innovatively.
* Excellent oral and written communication skills, creative thinking, and strong interpersonal skills.
* Experience working within a GMP environment.
Preferred Experience and Skills
* 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.
* Experience in writing and maintaining metrology and validation SOPs.
Other Details
* Employee status: Regular.
* Relocation: International.
* Visa sponsorship: No.
* Travel requirements: None.
* Flexible work arrangements: Hybrid.
* Shift: Not indicated.
* Valid driving license: No.
* Hazardous material(s): N/A.
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