Associate Director, Compliance and Quality Systems
- Facilitates all health authority inspections and BMS internal audits, including planning, execution and follow-up. Includes on-site inspections as well as remote (aka desktop) audits.
- Maintaining inspection readiness program for site personnel, including any periodic training and practice opportunities.
- Includes facilitation of BMS Global Regulatory Observation (GROe) program and BMS Policy/Directive review for site impact.
- Prepare required health authority documentation as part of maintaining active GMP certification as well as support of new applications to new markets.
- Oversee the site self-inspection (internal audit) function to ensure that the site meets current health authority and BMS corporate requirements.
- Manages and provided Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.
- Facilitates the Devens Site Quality Council by developing and monitoring the scorecard of key metrics, as well as the Site Quality Plan of key continuous improvement and emerging topics.
- Oversee the Quality Risk Management program including owning the site risk register.
- Oversee the Change Control program to ensure that change requests are properly assessed for impact.
- Oversee the Supplier Quality program to ensure that suppliers and materials are fit for use in GMP manufacturing, which includes material and supplier qualification, as well as oversight of life cycle activities such as supplier audits/agreements, complaints/investigations and change notification.
- Oversee the Training program to ensure that site colleagues have the training courses needed to perform GMP activities.
- Oversee the Records Management program to ensure that documentation is available for use according to mutually defined service level agreement.
- Includes ensuring that our Documents and Records Management strategy meets all health authority requirements for Data Integrity.
- Hires and develops qualified managers and staff.
- Ensures that staff have adequate training, education and experience to perform their GMP related job function effectively.
- Oversee budget adherence to department cost center.
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.
- A minimum of 7 years experience in biopharmaceutical quality or its equivalent with an additional 6 to 10 years of increasing management responsibility.
- Experience in building and growing an organization is desirable.
- Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics in a FDA and EMA regulated environment.
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
- Extensive knowledge of US and EMA GMP regulations and guidance.
- Proven experience in Inspection preparation and management is required.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Knowledge of computerized systems such as SAP, LIMS, Maximo, Trackwise, Syncade and DeltaV are desirable