Quality Assurance Manager
4 weeks ago
Job Summary
This position oversees and enhances the quality systems that support the repackaging of drug products through collaboration with contract repackagers. The goal is to ensure that the repackaged products meet the highest standards of quality and compliance.
Responsibilities
- Collaborate with contract repackager's management team and other business teams to develop systems, validations, and procedures that effectively integrate repackaged products.
- Responsible for oversight of change control, investigations, complaint investigation, annual product review, retain samples, validation protocols, deviations, non-conformances, and CAPAs.
- Review and approve investigations, validation protocols, deviations, and non-conformances for repackager compliance with cGMP's and regulatory requirements.
- Develop quarterly scorecard, to include on-time accountability and quality of expected deliverables/metrics.
- Position will require approximately 20% travel, to include periodic visits to the repackagers.
Qualifications
- Bachelor's degree in a related field, or equivalent work experience, preferred.
- 8-10 years of experience within the pharmaceutical industry preferred.
- 5+ years of experience as a Manager performing Quality Control in a pharmaceutical manufacturing or packaging environment preferred, with an emphasis on solid oral and oral liquid unit dose.
- Effective problem-solving and analytical skills, able to lead and influence others to drive improvements.
- Good knowledge in risk assessment and risk management.
- Strong working experience with Corrective Action and Preventive Action programs.
- Excellent hands-on computer skills with thorough knowledge of Microsoft Office, to include Excel and PowerPoint (statistics, graphing, presentations, etc.).
- Excellent verbal and written communication skills.
- Ability to travel 20%.
What is Expected of You and Others at This Level
- Manages department operations and supervises professional employees, front-line supervisors, and/or business support staff.
- Participates in the development of policies and procedures to achieve specific goals.
- Ensures employees operate within guidelines.
- Decisions have a short-term impact on work processes, outcomes, and customers.
- Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management.
- Interactions normally involve resolution of issues related to operations and/or projects.
- Gains consensus from various parties involved.
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