The Compliance Investigation Manager supports and ensures the success of a team of colleagues who investigate, solve, and document issues in the business while ensuring these issues are prevented from recurring. The Compliance Investigation team partners with different areas of the business to help those areas solve problems in support of business success. The Compliance Investigation Manager facilitates teamwork and alignment between the Compliance Investigation team and leadership between the team and areas of the business while tracking Compliance Investigation metrics and managing and driving action completion resulting from investigations. The goal of the manager is to ensure the Compliance Investigation team makes improvements in the business and bring value to the departments they support.
Responsibilities- Develops and maintains trending and metrics to track performance to include compliance metrics in the monthly Quality Trend Review and quarterly Management Review.
- Creates systems and governance to provide oversight and accountability for actions that result from investigations and issues in the business.
- Initiates CAPAs or Operational Excellence projects to drive wide sweeping system corrective actions or improvements from insight gained from investigations or deviation trending.
- Leads cross-functional project teams to drive process improvements that improve compliance, productivity, support systems, and safety.
- Liaison and facilitator between all departments to align parties in addressing issues in the business. Acts as a change agent to inspire positive change for the site.
- Responsible for tracking and follow-up on departmental commitments, investigations, change controls, validation and general compliance initiatives to ensure closure by defined due dates.
- Leads cross-functional teams on projects such as compliance initiatives, investigations, corporate policies writing and review, site SOPs, best practices and/or corrective action plans associated with regulatory inspections.
Qualifications- Bachelor of Science
- 5+ Years of Pharmaceutical Manufacturing Experience; at least 2 years in Laboratory, Manufacturing, Compliance, Validation or Quality Assurance environments.
- Strong Technical Writing and Background
- GMP Manufacturing /Aseptic Processing Experience
- Effective colleague engagement, team facilitation, quantitative analysis and communication skills.
- Ability to effectively coach/mentor/influence colleagues and manage diverse relationships.
- Ability to travel to and support Westport and Bridgeton sites as needed
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