Description
Biopharmaceutical Company seeks a Senior Manager working in Quality Systems. This person will be responsible for timely and compliant execution of Change Controls, Technical Quality Agreements (TQAs) and Annual Product Quality Reviews (APQRs). GCP is a must. A fantastic opportunity at a company that is expanding at a rapid rate.This role will assure compliance with regulations through continuous education of compliance requirements and foster continuous improvement of the Quality Systems. You will need great auditing technique and to have a strong knowledge of Good Clinical Practice.
Job Responsibilities required:
- Act as Change Control Manager/Coordinator and subject matter expert, facilitate all change control meetings and activities, and assure change control activities are performed in a compliant, timely and contentious manner.
- Oversee Technical Quality Agreement (TQA) management
- Maintain a status and priority schedule
- Oversee completion by facilitating meetings with internal and external stakeholders
- Assure agreements are in alignment with company policies
- Monitor compliance with agreements
- Coordinate completion of Annual Product Quality Reviews (APQRs) by facilitating consolidation/summarization of internal and contractor data. Assure timely completion and communication in alignment with company procedures and Quality Agreements.
- Foster continuous improvement for the Change Control, TQA, and APQR processes.
- Monitor quality metrics. Troubleshoot issues and support metrics improvements related to Change Control, TQAs, and APQRs.
- Act as a back-up for Product Quality Complaints and Devations/Events/CAPAs.
- Participate in or lead Quality System improvement project teams as required.
- Assists in partner audits and regulatory agency inspections as required.
- Demonstrate prudent judgment when deciding which records/issues require escalation to upper management.
Previous Experience/Skills required:
- Bachelor's degree and 11+ years of cross functional responsibility in Quality Systems.
- Excellent understanding of pharmaceutical regulations.
- Proficiency with MS Office and software programs for generating reports, presentations and statistics
- Proficiency with TrackWise.
- Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to effectively work with internal and external stakeholders.
- Technical writing experience.
If you want the opportunity to join a fast expanding company within a fast paced upwardly mobile atmosphere then apply today. Please upload your cv or call Andrew and Real Staffing on