Requisition ID: QUA006513
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 Director, Clinical Supplies Quality, Global Development Quality is responsible for leading the West Point Clinical Supplies Quality organizations in support of the clinical development programmes for the Merck portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced at West Point. This position reports to the Executive Director, Global Clinical Supplies Quality & Third Party Quality Management, and will have significant global responsibilities for the overall process ownership of clinical supplies finished goods batch disposition and regulatory compliance assurance. In addition, responsibility for management of significant quality events for potential or actual stock recoveries / recalls related to clinical supplies finished goods and ensuring overall compliance of supply chain design, including development of quality risk management / risk mitigation plans will also reside with this position.
Key requirements of the role also include ensuring the continued evolution of a quality culture across stakeholder groups via the development and implementation of effective and efficient compliance and business processes with a strong operational focus aligned with business drivers.
The position will require an in-depth close collaboration with the key stakeholder groups as well as multiple GDQ sites and functions that deal with the supply chain for clinical supplies. This will also include navigating dynamic, high impact and high visibility situations on a regular basis in relation to ensuring that Merck’s clinical development portfolio / pipeline is not disrupted due to issues with clinical supplies. Dimensions of the role include the direct support via a team of approx. 12 FTEs plus up to 6 contractors, clinical supplies disposition / issue resolution activities for over 300 clinical protocols at any time, supporting >10,000 clinical sites in approx. 70 countries. An advanced level of knowledge of the quality processes related to clinical packaging, labelling and regulatory compliance (e.g. FDA 21CFRPart210/211 and Annex 13 to the Eudralex Volume 4, GMP Guidelines) is required for this role in addition to in depth expertise and experience to enable the incumbent to exert influence with the stakeholder areas at senior levels.
In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:
- Ensure reliability of clinical supplies availability for Merck clinical trials via daily operational management for the finished goods disposition and supporting activities, with the associated potential for high impact to the development portfolio
- Assuring capacity planning, scheduling and operational processes and systems are managed and enhanced for clinical supplies disposition and associated activities
- Supporting the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures
- Provision of in-depth technical / quality expertise re; development of identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.
- Direct management of high profile and high impact significant quality events related to clinical supplies finished goods, e.g. potential recalls, including cross-functional interactions with diverse groups (e.g. Global Clinical Development, Global Regulatory Affairs, Global Compliance, MMD and MRL Legal,) at senior levels
- Coaching, mentoring and developing team members supporting their personal development and also colleagues in areas of expertise
- Assists, as part of the Global Clinical Supplies Quality & Third Party Quality Management Leadership Team, the development of strategic plans and translates and defines these in terms of related work processes and practices
- Bachelor Degree in Engineering, Biology, Chemistry or related field
- A minimum of 10 years of relevant experience working within the pharmaceutical industry or advanced Degree with 8 years relevant experience.
- Experience interacting with regulatory officials and external auditing parties
Primary skills include but are not limited to :
- Strong technical expertise in R&D activities specifically related to clinical supplies, coupled with the ability to interact with and influence stakeholder subject matter experts and senior leaders on various initiatives and issues
- Demonstrated operational management experience, including capacity planning and scheduling
- Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment
- Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives
- Demonstrated leadership, incl. strategy development and deployment experience with tangible delivered benefits in a clinical trials / supplies environment
- Demonstrated experience in quality risk management in the pharmaceutical industry
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
- Experienced and strong people manager with proven track record of developing talent
- Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels
- Strong project management skills and experience; ability to conduct well defined projects on complex topics