Job Description

This Senior Specialist position reports to the Rahway Site Compliance Lead in Global Development Quality and is responsible for leading and supporting activities that include, but are not limited to internal audits, GMP readiness, Health Authority inspections and general compliance initiatives.

Responsibilities include, but are not limited to:

• Independently leads and supports comprehensive internal audits of GMP facilities or systems supporting clinical suppliesmanufacture, testing, storage, and distribution to ensure compliance to applicable regulations, policies, and procedures.

• Issues report summarizing findings and tracks resulting CAPAs to satisfactory closure in order to maintain appropriate risk posture for the site.

• Maintains an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations.

• Provides support for the preparation and execution Health Authority Inspections.

• Proactively identifies, develops and implements opportunities for work/process improvement and efficiency.

• Represents Global Development Quality on cross-functional teams, ensuring the flow of information and providing Quality guidance.

• Develops and maintains metrics and key performance indicators to measure trends and improve quality performance. Presents outcomes to management and governing Quality Councils.

• Leads and supports GMP readiness activities for new manufacturing facilities, laboratories and support areas.

• Promotes a culture of quality and operational excellence.

• Proactively identifies areas for improvement and work across multiple organizations to influence and implement solutions.

Education:

• Required: Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline

• Preferred: Advanced degree

Required:

• Minimum 5 years of experience in Pharmaceutical or related industry

• Experience leading internal or external Good Manufacturing Practice (GMP) audits

• Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines

• Excellent attention to detail

• Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering

• Experience participating in US and EU health authority inspections.

• Strong leadership and collaboration skills

• Excellent verbal and written communication and presentation skills

• Proficiency with digital tools and computer applications; knowledge and competency in PowerPoint, Excel, and Word

• Ability to independently manage multiple priorities and projects

Preferred:

• Familiarity with R&D or clinical supply areas and processes

• Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.

• Active Pharmaceutical Ingredient experience and knowledge of ICH Q7

• Quality Risk Management

• Experience using AI tools and applications

• Experience with industry standard computer applications (e.g., Delta-V and/or PAS-X, SAP, laboratory notebooks, Veeva, LIMS, Empower)

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R338129