what in All Locations Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming       QA NEW PRODUCT MANAGER Job Company - Bristol-Myers Squibb Location -  Manati, Puerto Rico  US   Job Code - 37600 Position - Job First Active on: Friday, December 23, 2011 QA NEW PRODUCT MANAGER Ensure quality assurance functions are aligned to support the site business units. Review and approve product/ processes related documentation such as: validations, SOP's, etc. Provide quality support to the business unit to optimize compliance and efficiency. Assure the resolution of products and process issues associated to Quality Events. Support the inspection certification process. Provide guidance to the site change control activities to assure they are in compliance with all regulatory requirements. Support the QC/QA efforts during the transference and validations of parenteral products at the site. Support the site audit readiness activities related to parenteral products manufactured at the site. Approve product risk management plan and process FMEA's for parenteral products. Support the annual product review approval process for all the parenteral products, and recommends next steps and/or corrective actions based on trends. Ensure that corporate guidelines/policies are established within the Technical Operations Corporate framework, and are effectively implemented and monitored and assure that the manufacturing and packaging procedures are properly followed and adequate for their use. Write, review and implement departmental procedures to update them with current practices and regulatory requirements. Approve the certificates of analysis (COAs) for products, according to market requirements. Coordinate priorities to assure timely product releases for different markets. Assure an appropriate lot disposition for all parenteral products. Support departmental budget preparation activities. Promote and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc. Be a liaison in all new product site initiative. Support all site Initiatives in addition to the product transfer initiatives and any other assignments based on business needs. Ensure there are effective systems for the maintenance and calibration critical equipment and approve calibration requests. Review and approve equipment, utilities and facilities qualification and system life cycle documentation. Provide appropriate information to and obtain the qualified person's approval as required by the specific European Union (EU) regulatory authorities. Review and approve 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. Review supporting data for compliance with cGMPs documentation practices. Verify compliance with BMS policies and guidelines. Participate as quality representative or liaison in site projects. Support process/manufacturing decisions during audits with regulatory agencies. Perform pre-operational review form approval in the manufacturing and packaging area. Administer investigations and CAPA's management systems. Perform 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. Verify consistency with other site procedures and/or specifications. Review and approve investigations related to process, products, utilities, microbiology laboratory and calibrations. Approve corrective and preventive actions (CAPA's) and prepares CAPA Effectiveness report. Evaluate and approve critical area drawings. Serve as a liaison with internal and external customers. Own expiry date master procedure. Approve or reject specifications impacting drug products, raw material or packaging components. Ensure the designation and monitoring of storage conditions for quarantine materials and products. Ensure that an effective system for returns and salvages that include assessment, investigation and disposition is in place. Prepare site key performance and trending metrics.Participate in the Material Review Board. REQUIREMENTS - QUALIFICATIONS: QA NEW PRODUCT MANAGER BS in Natural Science (Chemistry, Pharmacy, Microbiology, Biology, Engineering or a related pharmaceutical science). Five (5) years of progressive managerial experience within the quality assurance function of the pharmaceutical/health care industry and regulatory agencies, with five (5) years of experience in one of the following areas: aseptic filling and finishing for liquid and lyophilized products, oral solid dosage and medical devices. Proficient in project management skills. Ability to develop and apply BMS's operating philosophy and to operate within company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas. Proficient in cGMP's and FDA/EMA regulations and requirements. Experience in containment technologies. Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions. Excellent verbal, written and presentation skills. Must be innovative and creative and utilize all available resources. Working knowledge in PC's and electronic tools. Excellent communication skills in both English and Spanish. Bristol-Myers Squibb Apply to this job! View Company Jobs Free Career Test Your Resume on 75 Job Sites

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