Job Summary
Collaborates with the Quality Assurance Sr Director in ensuring the development, implementation and review of Quality Systems so that they are adequate and compliant. Assists QA Sr Director with oversight of daily activities, including major projects, QA and Operations teams support; validation activities; Regulatory inspections, Change Control, KPIs and Events Management.
Salary Range: $119,149-$160,000 + 14% annual bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
- Responsible for the administration of the Quality System for the PU as directed by the site head in accordance with US Operations and Corporate policies and procedures.Reviews, and approves quality system documentation such as standard operating procedures, validation documentation, and manufacturing discrepancy reports.Provides cGMP guidance to all departments engaged in the production of pharmaceutical products.Initiates and implements quality improvements, change control and continuous improvement efforts.
- Supports batch disposition related activities, Right First-Time initiatives, and helps develop programs to encourage and support the relationship between operational efficiency and quality and compliance.
- Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventive actions and appropriate effectiveness measures.
- Has authority to make decisions for the PU QA department in internal and external meetings on behalf of the Director.
- Plans for resources and administrates budget, with regards to personnel, equipment, and facilities.
- Directs investigations of product complaints and manufacturing discrepancies for PU manufactured products and ensures completion of appropriate documentation.Interacts with the Vigilance and Medical Affairs Department as needed.
- Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors.Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
- Responsible for Gap Assessment review and approval, including those related to regulatory standards and changes.
- Develops human resources to better accomplish and perform in their duties as professional quality manager, supervisors, and technicians.
- Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics/KPI.
Requirements
- Bachelors in Science with a minimum of 8years work related experience including a minimum of 3 years as manager or above.Advanced degree strongly preferred.
- Advanced familiarity with regulatory requirements (FDA, EU, PIC/s, ICH)
- Advanced training or experience in cGMPs, GLPs, legal and ISO requirements.
- Experience in Project Management and Quality Systems implementation.
- Sense of urgency and flexibility in executing responsibilities
- Proficient in computer skills
- Excellent verbal and written communication skills
- Attention to detail
- Motivation and enthusiasm
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
