A leading pharmaceutical and medical device company is seeking a knowledgeable leader to manage the site’s quality assurance team.This position oversees the Quality Assurance Systems and staff, including all assessments and decisions impacting final disposition of finished goods (i.e. release or rejection) and must ensure that all corporate and governmental regulations and procedures are upheld.
PRIMARY DUTIES AND RESPONSIBILITIES
- Oversees QA staff including all aspects of performance management. Allocates QA resources according to the requirements of the work schedule and monitors to ensure that assignments are completed in a timely and efficient manner. Works directly with QC and other Operations staff when needed to coordinate cross functional work assignments.
- Acts with full authority and decision-making capacity for all QA decisions, with input from Quality Control, Director of Operations, and/or Director of R&D. QA’s mandate is directed from the Vice President of QA when consensus cannot be otherwise achieved.
- Oversees the QA batch record review process for final finished product and determines batch status (i.e. release, rejection, or product hold for further clarification or investigation).
- Assesses potential impact of proposed changes, incidents and processing non-conformances on the quality and suitability of the product for sale. Drives quality investigations to appropriate levels of corrective/preventive actions and closes in a timely manner, including tracking and prompt management of the customer complaints.
- Reviews and approves all product complaint/returns, evaluations and responses. Addresses all Pharmacovigilance/MDR reports with priority.
- Ensures that quality system is established, implemented, and maintained in accordance with: FDA GMP & QSR, ISO 9001, ISO 13485, MDD 93/42/EEC. All GMPs, SOPs, QSR, IS0 13485, CMDCAS and company policies must be followed. Serves as ISO “Management Representative.”
- Pursues quality improvements – oversees CAPA, QA aspects of scrap/rejection reduction, leads Continuous Quality Improvement, and/or ICH Q10 quality system life cycle management.
- Coordinates supplier qualification and approved status.
- Conducts internal auditing program and ensures that requirements of ISO and FDA are met. Ensures that written procedures are followed (SOPs) and managed in an effective manner.
- Oversees the performance of the Ennov system at Septodont-Louisville. Liaison with other Septodont staff for support and development/implementation of Ennov initiatives. Acts as QA liaison for AX activities.
- Reports on the performance of the quality system (Dashboard/Scorecard) to management as a basis for improving the quality system.
- Participates in inter-departmental discussions and teams to represent the Quality Assurance department interests and subsequently serves as a communication conduit to collect/distribute related information. In addition, coordinates applicable activities of the QA department as appropriate.
- Provides support to validation and technical study activities including the review and approval of data/documentation.
- Supports Regulatory Affairs activities as required, as related to obtaining/preparation of documentation required for related filings.
- Supports clinical studies as required (i.e. auditing).
- Manages the program of annual GMP training. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
- Bachelor’s degree in life sciences (e.g. Chemistry/Microbiology)
- Minimum of 5 years practical experience in a QA/QC function
- Proven ability to develop others and support/create effective teams.
- Minimum of 2 years previous supervisory experience
- Able to work independently with minimal supervision
- Ability to work on variety of projects simultaneously.
- Excellent verbal and written communication skills.
- Strong problem solving and decision making skills.
- Detail oriented, computer literate.