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Associate Director, Third Party Quality Management Analytical Testing
1 month ago
Job Description
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 analytical testing. 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, maintenance and accuracy of the Development Approved Supplier Listing, 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. Experience in medical device and/or combination products testing would be preferred.
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 incumbent would be the key quality representative attending and contributing at oversight and business review meetings with our Company and contractor personnel to discuss projects, 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 our Company 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 Chemistry, Biology, Engineering or related field.
Required Experience and Skills:
At a minimum the position requires a Bachelor’s Degree with 8+ years of relevant experience within the pharmaceutical industry. Advanced Degree with 5+ years relevant experience.
Strong scientific/technical expertise in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues relating to Analytical Testing.
Flexibility to travel up to 15% both domestic and international.
Preferred Experience and Skills:
Experience in medical device and/or combination products testing would be preferred.
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.
Experience in Biologics and/or Vaccine method development, characterization, technology transfer, and release.
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 months to 1 year span); integrating, managing, and/or coordinating similar/related teams, units, work processes or functions.
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