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

Job Description

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 key responsibilities of this role include:

• 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.

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

• B.S. with 5+ years of post-degree relevant industry 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 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.

 

Preferred Experience and Skills

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

• 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.

Learn more about Analytical Research and Development (AR&D)

Tag: #AR&D

Required Skills:

Adaptability, Cross-Functional Collaboration, GMP Compliance, GMP Documentation, Inspection Readiness, Laboratory Testing, Standard Operating Procedure (SOP), Training Documents

Preferred Skills:

Communication, Diversity, Equity, and Inclusion, FDA Inspections, GMP Environments, Pharmaceutical Industry, Process Improvements, Teamwork

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$106,200.00 - $167,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Domestic

VISA Sponsorship:

Yes

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:

05/4/2026

*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.