Job Summary
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 \& 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 technical competence; can analyze data and interpret results to make scientifically valid conclusions.
- Strong organizational and interpersonal skills and the ability to work collaboratively with others.
- Proficient in complex procedures and problem solving.
- Proven ability to manage with leadership and independence with a focus on excellence, innovation, and teamwork.
- Proficient in Microsoft Office - Word, Excel, PowerPoint
- Comprehensive knowledge of pharmaceutical GMPs
- Comprehensive knowledge of laboratory techniques and safety precautions
- Comprehensive knowledge of WHMIS and biohazard safety
- Comprehensive knowledge of regulatory/industry guidance
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
