Associate Director, External Quality - Drug Product ManufacturingMerck & Co., Inc - Rahway, NJ
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its
legacy for over a century
. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The incumbents will be responsible for serving as the quality representatives for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies, on behalf of Merck. Key activities this position would be responsible for include: leading internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, 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.
The position will be heavily involved in close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including GMP qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between R&D and Commercialization activities and develop a strong working relationship with commercial external quality management personnel. The incumbents would be the key quality representatives attending and contributing at oversight and business review meetings with Merck and contractor personnel to discuss projects, financial, operational/quality and overall performance topics.
In addition to the job specific responsibilities discussed above, the incumbents are expected to independently execute on the following:
Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision
Provides project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment.)
Leads Quality-related reviews, cross-functional process teams and/ or investigations, serving as a subject matter expert
Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities
Makes independent decisions and acts with authority to carry out required actions
Coaches, mentors and develops colleagues in areas of expertise. Leads others in a matrix/management environment
Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity. on cross-functional and/ or cross-divisional basis
Identifies trends and/or potential compliance gaps and proactively leads the resolution of long-standing or significant issues affecting quality and efficiency.
Leads communication, and serves as Quality spokesperson, on a variety of Quality or compliance-related issues.
Interprets complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders. Reviews draft policy and standards.
Communicates with senior management within Merck and the contractor organization. Facilitates and/or prepares cross-functional management presentations.
Identifies and leads implementation of Contractor and Supplier System improvements.
Travel up to 20%.
A Bachelor’s Degree in Engineering, Biology, Chemistry or related field with at least 10 years of relevant experience within the pharmaceutical industry OR an Advanced Degree in Engineering, Biology, Chemistry or related field with at least 8 years relevant experience.
Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues in the following areas of Drug Product (Non-sterile) manufacturing.
Must be able to travel up to 20% both domestically and internationally.
Strong compliance knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment
Strong understanding of regulatory agency regulations and requirements
Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives.
Ability to independently interact with regulatory officials and external auditing parties
Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process.
Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
Strategic view of project issues in a Quality Systems environment
Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
Demonstrated skills in communicating (oral and written) effectively with diverse individuals/ groups
Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise
Demonstrated skills in leading; operational planning (3 mos to 1 year span); integrating, managing, and/or coordinating similar/ related teams, units, work processes or functions.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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applyAssociate Director, External Quality - Drug Product Manufacturing Merck & Co., Inc - Rahway, NJ, United States
Merck has a long and rich history of working to improve people's health and well-being. Through the years, our researchers have helped to find new ways to treat and prevent illness - from the discovery of vitamin B1, to the first measles vaccine, to cold remedies and antacids, to the first statins to treat high cholesterol. Our scientists also have helped develop many products to improve animal health, including vaccines and antibiotics. While we are proud of our past, we are enthusiastic about the future of this new company and we are excited to help create a healthier, brighter future for people around the world.
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