Merck Director, Clinical Release in Rahway, New Jersey
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Director, Clinical Release Quality, External Quality is responsible for leading the Clinical Supplies Quality organization in support of the clinical development programs for the Company’s portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced at our company’s facilities and/or External Partners. This position will include global responsibilities for the strategic oversight and process ownership of clinical supplies activities. In addition, responsibility for management and execution 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. This will also include navigating dynamic, high impact and high visibility situations on a regular basis in relation to ensuring that clinical development portfolio / pipeline is not disrupted due to issues with clinical supplies. 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 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
Directing 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 at senior levels.
Coaching, mentoring and developing team members managing their personal development and also colleagues in areas of expertise.
Position Qualifications :
Bachelor Degree in Engineering, Biology, Chemistry or related field.
At least 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
Strong technical expertise in Research& Development (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.
Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Requisition ID: R84363
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