Summary: Responsible for overseeing a team of QA employees and their prospective area(s) and/or assignments.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions:
– Master records
– executed records
– failure investigations
– Change Controls
– Validation protocols and summary reports
• Approves various documents relating to area function, including those listed above.
• Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
• Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
• Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
• Participates in regulatory and customer audits. Interfaces with customer/partner quality organizations.
• Participates on internal committees/teams, as required.
• Provides advice and direction to other company departments on quality and regulatory issues.
• Acts as an auditor on behalf of the company.
Education and Experience:
• BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired. Minimum 7 years’ experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience.
• Eligibility to act as a Qualified Person (QP) in accordance with EU directives preferred.
• Experience in startup operations an advantage.