A Leading Biotechnology Company is looking to expand their Quality Control team with a Sr. Manager Quality Control position! This global company conquers Life Sciences in all areas to make sure their patients live a cleaner, healthier life. Want to join?
- Ensure the QC groups successfully ensure the quality of all GMP manufacturing activities, executing manufacturing and QC records in accordance with specified timelines.
- Ensure the QC groups successfully perform activities to meet specified timelines. Ensure the receipt, storage, testing, and reporting process is robust and continually seek ways to improve the process both in terms of effort expended, timeliness of completion, and quality of work performed/ quality of the disposition of the samples.
- Ensure the resources utilized throughout the QC organizations are appropriate for the tasks assigned and ensure the GMP requirement for appropriate staffing levels in all aspects of QC is continually met while simultaneously supporting efficiency improvements that reduce the amount of work/time expended on specific tasks.
- Conduct strategic organization planning for the group for a 3 - 5 year look forward.
- Ensure the timely review of batch-relevant testing and records, SOPs, investigations, corrective actions, change controls, technical documents (especially method development/transfer reports), and the adherence to Quality Agreements.
- Responsible for leading the QC Organization and managing & coordinating the safety and quality activities of the QC management team engaged in the sampling, receipt, storage, testing, and inspecting of products and raw materials to ensure compliance with quality standards and production and delivery schedules.
- Participates in revisions, providing input, as necessary. Participates in Regulatory Inspections and Customer Audits as needed for GMP, policy, and procedure defense, and as an SME.
- Provides overall departmental feedback to Site Quality Head. Approves department budget and initiates cost control measures.
- MS in Biochemistry, analytical chemistry, or related field plus a minimum of 8 years of relevant experience. A BS or BA with a minimum of 10 years of relevant experience
- 12+ years of experience in a GMP environment, with a minimum of 8 years of experience in QC of biopharmaceuticals and 3 years of experience in Quality Assurance.
- 6+ Years prior supervisory or management experience required.
- Lean labs understanding is a requirement.
- Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation.
- Ability to understand, create, maintain, and deliver on budgets.
- Extensive knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Applies GMP regulations and other international guidelines to all aspects of the position.
- Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.