Associate Director Quality Control
|Contact Name:||Laurentina Kennedy|
Associate Director Quality Control
The Associate Director, Quality Control is responsible for quality control activities in support of commercial operations for drug substances, APIs and drug product, ensuring compliance with regulatory requirements and international GMP/quality standards. Through collaborations with CMO partners the individual in this role ensures that QC support is provided to commercial objectives including product supply, process improvements and ensures successful outcomes in regulatory filings and inspections. Furthermore, the Associate Director of QC ensures the appropriate oversight and direction of analytical activities at contract laboratories (CTL) and contract manufacturing operations (CMO).
Lead quality control activities at contract laboratories and contract manufacturing operations.
Ensure required QC support to maintain product supply in alignment with product team goals and objectives
Provide QC support to ensure successful outcomes in regulatory filings, communications, meetings, and inspections.
Ensure compliance with regulatory, GMP and quality standards.
Ensure management of laboratory investigations, change controls, CAPAs and commitments in a compliant manner.
Management of Stability programs in collaboration with CMO's
Collaborate with external partners to ensure QC requirements are fully represented across the global organisation
Collaboration with internal stakeholders including Global Technical Operations and Supply Chain, QA, and Regulatory Affairs to ensure business objectives are delivered
Actively lead QC continuous improvement opportunities
Active participation in the Quality Management Team to support external manufacturing activities
Direct responsibility for QC management/oversight of the following areas:
Management of commercial contract test/development laboratories and associated QTA's
Management and qualification of reference standards associated with APIs and drug products
Leading OOS/OOT investigations in partnership with CMOs ensuring closure in compliant manner
Lead for managing compendia updates on all commercial products
Management of specifications for raw materials, components, drug substances, APIs and drug products
Stability data review and statistical analysis lead for products
Lead for analytical method transfers/validation programs
Lead for analytical method troubleshooting and support with CMO
Perform audits at Contract Test Laboratories and CMOs
Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company-specific GMP activities.
Collaborate with regulatory affairs to support regulatory submissions and response letters as directed.
Highlight any risks associated with maintaining supply of commercial drug products and develop effective mitigations
Staff management if required
Ability to travel up to 20%
Qualifications and experience
BSc, MSc or PhD in chemistry, biochemistry, pharmaceutical science, or related field. 8-10 years progressive experience from individual contributor to manager/supervisor of quality control (or related analytical development, pharmaceutical development, or manufacturing) function.
Demonstrated experience in Regulatory Authority interactions (filings, inspections).
Experience of managing diverse laboratories (including contract laboratories) at different geographic locations.
Analytical experience with diverse range of product formulations is desirable
Customer-orientated with excellent communication skills and the ability to apply pragmatic logic to problem-solving and issue resolution.
For further information on this Associate Director Quality Control position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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