Senior Specialist, External Capabilities Validation & Compliance (GxP Compliance & Documentation), Pharmaceutical Analysis & Digital Technologies

MSD • Rahway, NJ

1d • Hybrid

About The Position

The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Research Laboratories Division is seeking applicants for a senior specialist position in the GxP compliance and documentation team to support the global analytical organization. The position will be based at the Rahway, NJ research facility. The Compliance Senior Specialist 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 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.

Requirements

• Bachelor’s degree, or higher, in analytical chemistry or related field.
• Minimum 5 years of experience in pharmaceutical or related industry supporting analytical laboratory testing or as quality assurance for laboratory areas.
• Experience with Audits & Inspections.
• 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.

Nice To Haves

• Demonstrated commitment to diversity and inclusion.
• Experience leading a team for a common goal.
• Experience authoring SOPs for GMP analytical laboratories.
• Experience supporting GMP documentation and training within the pharmaceutical industry.
• In-depth knowledge of ICH guidelines, CFR requirements, the Eudralex, and other governing regulations.

Responsibilities

• Management and oversight of Good Manufacturing Practices (GMP) documentation, training, and standard operating procedures (SOPs) for the global network.
• Lead Audit and inspection activities for analytical groups primarily at the Rahway 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 primarily at the Rahway site.
• Drive harmonization of analytical procedures across the global network.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees