Manager, Compliance Investigation

Responsibilities

• Develops and maintains trending and metrics to track performance, including compliance metrics in the monthly Quality Trend Review and quarterly Management Review.
• Creates systems and governance to provide oversight and accountability for actions resulting from investigations and issues in the business.
• Initiates CAPAs or Operational Excellence projects to drive wide-sweeping system corrective actions or improvements from insights gained from investigations or deviation trending.
• Led cross-functional project teams to drive process improvements that enhance compliance, productivity, support systems, and safety.
• Liaison and facilitator between all departments to align parties in addressing issues within the business.
• Acts as a change agent to inspire positive change for the site.
• Responsible for tracking and following 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.