Associate Director, Third Party Quality Vendor Liaison Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The incumbent is responsible for serving as the quality representative for, and providing quality oversight of, contractors performing manufacturing and analytical testing of Active Pharmaceutical Ingredients for use in 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, working with vendor on inspection readiness activities, development and creation of contractor related metrics, conduct of contractor “deep dive” quality assessments such as 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 API Quality Disposition, Process 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 in the API space. The person would be the key quality representative 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 incumbent is 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.
Education Minimum Requirement:
- Bachelor Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
- A minimum of 10+ years of relevant experience working within the pharmaceutical industry. Advanced Degree with 8+ years relevant experience
Preferred Experience and Skills:
- Fluency in Chinese strongly preferred
- Strong compliance knowledge of regulations governing API intermediate and API manufacture coupled with proficiency in interpreting and applying GMPs to a R&D environment, strongly preferred
- Strong understanding of regulatory agency regulations and requirements
- Strong scientific/ technical expertise in API development, manufacture and testing, perspective and judgment 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
- Demonstrated experience in quality risk management in the Pharmaceutical industry
- Strategic view of project issues in a Quality Systems environment
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
- Strong 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
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Qual Assurce - 3rd Party Manuf
Job Title:Assoc. Dir, External Quality
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Pharmaceutical, Strategic Planning, Law, Procurement, Science, Strategy, Research, Legal, Operations