Senior QC Manager
Posted on Feb 9, 2021 by Real Staffing Group
Reporting to the Director, Quality Control, the Senior Manager, Quality Control is responsible for supporting quality operational activities for specific product portfolios within an assigned business unit.
The successful candidate will support the representation, communication and management of quality issues with internal partners, (including but not limited to business unit, technical operations, supply chain and R&D) and external partners (including but not limited to CMOs and 3rd party laboratories).
The Senior Manager, Quality Control will also support and execute quality operational, strategic and team goals for their product portfolio in order to assure the highest quality standards and regulatory compliance.
This position is a member on a quality operational team responsible for the quality operational activities for specific product portfolios within an assigned business unit. They are responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements of deviations, CAPAs, change controls and product complaints.
This team member is further responsible for ensuring the highest quality standards for the product portfolios by the tracking and monitoring of batch, stability and quality control data. This team member supports and serves as the analytical, technical and quality operational expert on the product portfolios within the assigned business unit.
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups. The companies global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
Qualifications and Skills Required:
- 5+ years pharmaceutical experience with at least 3 years in a QC position supporting pharmaceutical production and/or testing.
- BA/BSc in Chemistry, Biology, or equivalent required.
- Authoring/reviewing regulatory submissions of CMC sections.
- Detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
- Experience with commercial and clinical development method implementation.
- Strong working knowledge of USP, EP, ICH, cGMP, FDA and EU requirements and guidelines.
For immediate consideration please reply with an up to date CV. Not sure yet? No CV ready? Please pop me an email to schedule some time to chat.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales