Director Legal, Manufacturing Division

Job Description

The position provides legal support and counseling to business clients on a wide range of manufacturing compliance issues (including cGMP) around the world. The position requires the ability to provide timely, practical and compliant solutions while managing legal risks. The position reports to the Associate Vice President, Legal - Manufacturing Regulatory, Labor & Employment, and Safety & Environmental. This is a hybrid role 3 days/ week in office. Ideally the candidate will work in our Rahway NJ office but also open to our West Point, PA or Upper Gwynedd, PA locations.

Responsibilities include:

• Providing day-to-day legal advice to the quality and supply chain organizations;
• Reviewing regulatory submissions and providing strategic advice on interactions with regulators;
• Providing legal support for regulatory inspections;
• Maintaining understanding of current Good Manufacturing Practices (cGMP);
• Providing advice on manufacturing-related agreements.

Required Qualifications & Skills:

• A bachelor's degree from an accredited institution.
• Graduate of an accredited US law school, with admission to the Bar of New Jersey or another state.
• Five (5) or more years of regulatory experience in a law firm or corporate setting
• Excellent teamwork, communication (written and oral) and analytical skills, and a high degree of business acumen;
• Experience in managing a significant workload, with the ability to juggle competing tasks in a fast paced and challenging environment;
• Willingness to work out of an office in Rahway, New Jersey or North Wales, Pennsylvania no fewer than three days a week.

Preferred Expereince:

• cGMP experience;
• Pharmaceutical experience;
• Experience dealing with regulatory authorities, such as FDA, EMA

OGC2026

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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. Asa 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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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.

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

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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.

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Relocation:

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