Job Description Associate Director, Third Party Quality Management Drug Product The incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. The position will be heavily involved in close collaboration with the contractor quality and technical personnel and will partner with internal development teams on objectives utilizing external contractors including GMP qualification as well as the support of small and large molecule development programs. Experience in medical device and/or combination products would be preferred. Key Responsibilities: Activities that this position would be responsible for include: Leading overall quality relationships with contract manufacturing organizations, Negotiation of site and global Technical and Quality Agreements, Participating in contractor GMP audits as a Subject Matter Expert, Conduct of contractor “deep dive” quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform, Supporting product development teams in outsourcing activities to enable our diverse pipeline. Serving as the bridge for quality oversight between research and development and commercialization activities. Communicating, and serving as Quality spokesperson, on a variety of Quality or compliance-related issues. Required Experience : Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within biopharmaceuticals. Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision. Providing project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment). Identifying trends and/or potential compliance gaps and proactively leading the resolution of issues affecting quality and efficiency. Interpreting complex regulatory requirements for various audiences, including source area management, and facilitating communication of these requirements across stakeholders. Preferred Experience: Experience related to medical devices and combination products, Engagement with small and/or large molecule drug development programs from early phase through commercialization, Participation with contract manufacturing of clinical supplies. Education Minimum Requirement: Bachelor's degree in relevant area related to engineering, chemistry, or biology. 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. 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: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 12/10/2024 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. Requisition ID: R322787 J-18808-Ljbffr