Senior Manager - QC Technical
The Senior Manager for QC Technical is responsible for all activities associated with new product introduction, laboratory support, informatics and management of the sites stability programme at Forest Laboratories Ireland.
The Senior Manager for QC Technical is responsible for providing guidance and direction to Quality Control supervisory staff in the Technical group and ensures the QC Technical team personnel perform their duties in compliance with all applicable laws, regulations, GMP, and internal Company policies. The position reports to the Associate Director of Laboratory Operations and may act as a deputy for the AD for Laboratory Operations in their absence.
- Ensure the functions of the Quality Control Technical team are completed in a timely and efficient manner.
- Identify and prioritize resource requirements in association with the Assoc. Director for Laboratory Operations based on project plans and time lines and allocate and schedule resources to meet regulatory and commercial requirements.
- Establish the expectation and standards, and the supportive environment, to ensure that the analysts, specialists and reviewers involved in the Analytical group have the capability to meet performance expectations.
- Manage transfer and validation projects for the Technical Team at Forest Laboratories.
- Maintain accountability for Analytical group performance metrics around product and raw material testing.
- Ensure all generated data reports from the Analytical testing group are current, accurate, and distributed according to defined procedures.
- Ensure continual improvement of all associated documentation (SOPs and ‘On the Job’ aids) and that they are current, accurate, and clearly define process and role responsibilities.
- Encourage process innovation and continuous process improvement in the QC Analytical function.
- Ensure that routine testing operations for finished product, stability and raw materials are in compliance with HPRA, FDA, ANVISA and other country regulations as appropriate.
- Represent the QC Analytical function with all internal stakeholders.
- Implement / execute QC goals consistent with Forest local site goals and strategy. Develop plans to achieve those goals and prioritize and execute those plans in conjunction with Assoc. Director for Laboratory Operations.
- Act as delegate for the Associate Director of Laboratory Operations in their absence
- Bachelor’s Degree or above in Analytical Chemistry or Instrumentation
- At least 10 years relevant analytical experience.
- At least 3 years of relevant supervisory experience.
- Demonstrated success in managing a team in a pharmaceutical testing environment
- Experience in managing technical transfer activities and working to strict timelines.