Sr Director, Quality Control
Winnipeg, Manitoba 1 day ago
Job Description
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed:to protect life.
Job Summary
Reporting to the Global Head of Quality Operations, the Sr. Director, Quality Control is responsible for all Emergent Winnipeg Quality Control functions and assuring the integrity and reliability of all QC data. This is achieved by standardization of QC operations, resource allocation and monitoring, staff development and training, performance monitoring of analytical methods and lab operations, communication with and support of stakeholders, on:going management review, and continuous improvement of lab operations. The Sr. Director also works with site leadership to assure adequate support for site operations.
Responsibilities
- Ensures appropriate data governance processes are in place that provide a high level of assurance of the integrity and reliability of the data generated by, or on behalf of, the QC function.
- Staff development by ensuring adequate technical and/or leadership training is provided, providing growth opportunities, and succession planning for the QC function.
- Sets goals and objectives for the department considering site, business unit, and corporate objectives.
- Operational planning and prioritization of activities to achieve those objectives including any necessary resource planning and allocation. This also includes creation and management of annual operating and capital budgets for the department, including lifecycle capital planning.
- Ensures processes are defined, implemented, and effective for all Quality Control lab operations to ensure, minimally, that laboratories and procedures are in compliance with GMP requirements, but, ideally, will proactively assess needs and initiates continuous improvement projects to improve the effectiveness and efficiency of lab operations.
- Responsible for oversight and management of multiproduct stability, specifications, and trending programs, ensures that phase:appropriate testing is planned and executed throughout product lifecycle.
- Collaborates with other functional areas and works with cross:functional teams to promote understanding and achieve strategic objectives. Communicate required departmental work activities to ensure that corporate, project and unit objectives are completed efficiently within defined timelines.
- Provides guidance on QC regulatory strategy, directly supports agency interactions / discussions on analytical issues, and provides strategic direction and resources to support writing of license applications and amendments.
- Participate in internal and external/regulatory audits and manage corrective actions/responses related to QC.
- The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience and Skills
- The completion of a graduate:level degree in chemistry, biology or related field of study accompanied by a minimum of eight years directly related experience in a recognized professional or technical/scientific field; or an equivalent combination of education and experience.
- Ten+ years' experience in a senior leadership role. Experience in a pharmaceutical cGMP environment is strongly preferred.
- Proficient and professional communicator, verbally and in writing.
- Can connect lab operations and analytical capabilities with business objectives and effectively communicate to other business leaders.
- Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
- Demonstrated techn
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