Job: Sr Director Quality Assurance, Medicago, Durham, NC
Sr Director Quality Assurance
Durham, NC 27711 United States
Life ,Disability & EAP
Tax Preferred Accounts
Additional Benefits: Healthy Lifestyle Program: Medicago will reimburse Employees 100% of your membership dues for eligible gym/fitness membership expenses, Education Assistance, Adoption Assistance, Retirement fidelity investments.
Let’s grow tomorrow, together!
Would you like to join a team of passionate people who will help you learn and actively participate in the company's success like nowhere else? Then read on and become part of our story!
How will you help change the landscape of technology and innovative products at Medicago?
The Quality Assurance Sr. Director, reporting to the VP of Quality Assurance, will be the Head of Quality of our Durham site and a key member of the Site Leadership Team.
The Sr. Director leads the site’s Quality Assurance organization, with direct management responsibility for QA managers and sr. managers and accountability for ensuring that the QA team has the technical and professional skills, organizational structure, capacity, and business processes in place to meet Medicago’s expectations. The incumbent will have a lead role in ensuring the provision of world-class quality products to our customers through ensuring robust quality processes and a continuous improvement mindset throughout the site.
Manage and coordinate the Quality Assurance related activities of the site as well as supporting the QA team in a fast-paced and highly regulated environment;
Provide Quality leadership and direction to support business operations and development of the site quality strategy;
Accountable for oversight of the site’s QMS to ensure compliance with GMP regulations, including Health Canada, FDA and EU as well as alignment to the pertinent corporate guidance and policies;
Accountable for the release of products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company requirements;
Act as a leader and work closely with collaborators to establish strategies in creating and implementing efficient and appropriate processes as well as appropriate reporting and monitoring tools supporting a continuous improvement mindset;
Prioritize departmental activities according to corporate objectives;
Lead, participate and sponsor specific Quality related projects in accordance with the company’s goals and business objectives;
Participate in departmental growth and recommend/prepare and respect budgets according to corporate objectives;
Responsible for day-to-day management, setting objectives, coaching and developing managers and sr. managers and performance appraisal;
Perform other duties as required.
15+ years of experience in a highly GMP regulated, commercial environment biotechnology /pharmaceutical industry
Minimum 8 years’ senior quality assurance leadership role in the bio/pharma industry
Holds a bachelor’s degree in a relevant field (microbiology, biochemistry, biology)
Expert understanding of appropriate global drug and biological cGMP regulations, requirements and standards, including US-FDA, Canadian Health Canada and EU regulations are a must
Ability to manage multiple projects in a dynamic and fast paced environment
Ability to communicate effectively both orally and in writing including to cross-functional partners and senior management
Strong manager with track record of recruiting and developing teams and individual talent
Self-motivated and ability to manage time working on multiple projects simultaneously
Resourceful, well organized, highly dependable, efficient and detail orientated
Confident and Assertive
Medicago is changing the game!
Our Vision: A world better prepared to deal with any disease.
Our Mission: To create and deliver effective responses to new global health challenges.
Innovation, collaboration, integrity, adaptability, ownership and involvement of our colleagues are the keys to the success of our research. We have been cultivating the future together since 1999.
Medicago's journey is a story of innovation and perseverance. Even the company's name - the Latin name for alfalfa, the first plant we worked with - is a reminder of our culture of adaptability. We're proud of our humble beginnings and our current growth and global reach.
As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.
Medicago promotes an open and inclusive work environment for all our employees.
It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.
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