Associate Manager, QA Investigations

Role Summary

Associate Manager, QA Investigations is responsible for oversight of quality review, quality approval, and management of deviation events, investigations and CAPA.

This role collaborates across QA to provide support to investigation teams and drive quality outcomes while ensuring adherence to regulatory requirements and current good manufacturing practices (cGMPs).

Responsibilities

• Manages a team with direct oversight of review and approval for deviations, laboratory investigations and corrective actions.
• May review, verify and approve system records.
• Collaborates across QA to provide succinct support to investigation teams to drive quality outcomes.
• Approves and reviews SOP revisions.
• Provides direction for cross-functional study team meetings and interacts with subject matter authorities.
• Provides input for error prevention and corrective actions based on investigational findings.
• Involved in post-production management of events as required to facilitate closures to meet the required timelines.
• Serves as a subject matter authority to present topics to management and during inspections.
• Monitors quality system metrics including deviations, corrective actions, change management and controlled document workflows.
• Drafts and implements long-term planning for the process, staff and budget.
• Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.).
• Makes decisions and develops and implements policies.
• Ensures that policies and procedures are effectively coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs).

Qualifications

• 6+ years of relevant cGMP manufacturing experience.
• 3 years of supervisory experience. May substitute proven experience for education requirement.
• Have previous quality experience in the pharmaceutical industry.
• You continuously seek to improve processes for improved performance.
• Enjoy leading a team of quality-minded professionals.

Education

• BA/BS degree in Life Sciences or related field.