QA Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Ensures quality assurance functions are aligned to support the site business units. Reviews and approves product / processes related documentation such as: Validations, SOP’s, etc Provides quality support to the business unit to optimize compliance and efficiency. Assures the resolution of products and process issues associated to Quality Events. Supports the inspection certification process. Provides guidance to the site Change Control activities to assure they are in compliance with all regulatory requirements. Supports the QC/QA efforts during the transference and validations of parenteral products at the site. Supports the site audit readiness activities related to Parenteral Products manufactured at the site. Approves product risk management plan and process FMEA’s for parenteral products. Supports the Annual Product Review approval process for all the Parenteral products, and recommends next steps and/or corrective actions based on trends.

Ensures that Corporate Guidelines/Policies are established within the Technical Operations Corporate framework, and are effectively implemented and monitored and assures that the manufacturing and packaging procedures are properly followed and adequate for their use.

Writes, reviews and implements departmental procedures to update them with current practices and Regulatory requirements.

Approves the Certificate of Analysis (COAs) for products, according to market requirements.

Coordinates priorities to assure timely product releases for different markets.

Assures an appropriate lot disposition for all parenteral products.

Supports departmental budget preparation activities.

Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.

Supports all site Initiatives in addition to the product transfer initiatives and any other assignments based on

business needs.

Ensures there are effective systems for the maintenance and calibration critical equipment and approves calibration requests.

Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.

Provides appropriate information to and obtain the Qualified Person’s approval as required by the specific European Union (EU) regulatory authorities.

Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements.

Reviews supporting data for compliance with cGMP documentation practices.

Verifies compliance with BMS Policies and Guidelines.

Participates as quality representative or liaison in site projects

Supports Process/Manufacturing decisions during audits with regulatory agencies.

Performs pre-operational review form approval in the manufacturing and packaging area.

Administers investigations and CAPA’s management systems

Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.

Verifies consistency with other site procedures and/or specifications.

Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.

Approves Corrective and Preventive actions (CAPA’s) and prepares CAPA Effectiveness report.

Evaluates and approve critical area drawings.

Serves as a liaison with internal and external customers.

Owns expiry date master procedure.

Approves or reject specifications impacting drug products, raw material or packaging components.

Ensures the designation and monitoring of storage conditions for quarantine materials and products.

Ensures that an effective system for returns and salvages that include assessment, investigation and disposition is in place.

Prepares site Key Performance and trending metrics.

Participates in the Material Review Board.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com