Job Title: Quality Systems Manager I
- Responsible for quality management systems and processes, to support GXP operations at the Oncology & Biologics (TBOS) organization and its applicable alliance partners and suppliers.
- Serves as a primary TBOS quality systems representative for global quality management system processes, which include: CMC Change Control and Post Market Commitments, and Annual Product Review/Product Quality Review (APQR) for TBOS commercially marketed products.
- Supports the strategic compliance direction for critical quality management system processes, including validation, and data integrity.
- Support implementation and roll-out of the global company electronic quality management systems workflows.
- Monitors/ensures that site specific quality system workflows remain in compliance and that performance metrics are reported per procedural, company and/or regulatory requirements.
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies related to quality systems, and support and/or represent the Quality Systems functional area as a subject matter expert (SME).
Lead the CMC Change Control and APQR systems for the company.
This position is focused primarily on facilitating the CMC Change Control and Annual Product Review/Product Quality Review (APQR) systems and for providing Quality Systems support for Commercial GMP Oncology and Biologics pharmaceutical operations related activities for which TBOS is responsible. This individual works cross-functionally in a virtual setting, interacting routinely with other company sites and Alliance Partners to ensure global compliance, consistency and efficiency.
- Supports Commercial CMC Change Control Review Board meetings for the seven or more Commercial products for which TBOS either has quality responsibility for or is the Market Authorization Holder.
- Serves as Change Control Coordinator for two global Commercial products
- Monitors and completes change controls related to Quality topics.
- Initiates, revises, and reviews controlled cGMP documents including Procedures and reports.
- May execute and/or reviews Quality System-related validation test scripts and documents.
- Supports creation of training materials on department specific procedures and systems.
- Collects data, calculates, and reports on departmental and site performance metrics.
- Interacts with management, peers, subordinates and externally, to assess and improve the adequacy of the quality management system processes and procedures.
- Assures quality and compliance of department work product.
- Maintains knowledge of current applicable global regulatory requirements.
- Applies knowledge of cGMPs on a daily basis.
- Manages day-to-day operations independently.
- Presents viable alternatives within problem resolution and assists to ensure risk mitigation.
- Routinely partners with senior management on critical issues.
- Responsible for mentoring/coaching/training of staff both at site and externally.
- Determines or ensures proper sequencing of project activities, such that activities are conducted in a timely and efficient manner, project milestones are met, and compliance is maintained.
- Meets with individual employees and/or groups, both on site and or remotely on a regular basis to discuss, prioritize, and assign work and projects.
- Meets with functional group on a regular basis to discuss routine activities, individual projects and departmental goals.
- Develops and maintains strong internal relationships both within the Quality organization and cross-functionally.
- Minimum BA/BS with 6+ years or Masters Degree in any Life Sciences discipline with 4+ years relevant experience.
- Must have previous industry experience in a regulated environment, preferably a broad-based Quality and Regulatory background.
- Must have Commercial Change Control experience, preferably with global products.
- Must have direct experience with Quality Systems within the Life Science industry.
- Must be able to communicate effectively with employees, peers and management.
- Must be able to read, write and converse in English.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- Experience with CatsWeb or TrackWise applications desired, but not required.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Strong interpersonal skills and must be able to work effectively and efficiently in a team environment.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Positive work attitude that supports teamwork and continuous improvement.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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