Manager, Quality Assurance & Incoming Laboratory
About the Job
Accountable for providing Quality Assurance guidance to the Oral Solid Dosage area to assure these products are manufactured in accordance with cGMP’s, regulatory requirements, guidelines and product registrations. This position will be responsible for manage and lead the incoming laboratory for the facility (which includes material testing, disposition of raw materials and packaging components). This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function. Ensures Quality Assurance and Quality Control functions (Incoming Laboratory) 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 units to optimize compliance and efficiency. Assures the resolution of products and process issues associated to Quality Events. Assures that existing laboratory methodology at the site is robust and that validation is maintained within BMS guidelines. Establishes a system for disposition of raw materials, API’s, packaging and labeling materials to ensure an effective process/system for disposition of raw materials, API’s, packaging and labeling materials. Approves or rejects specifications impacting raw material and packaging components. 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 Oral solid Dosage and parenteral incoming materials at the site. Supports the site audit readiness activities related to Oral Solid Dosage and incoming materials at the site. Approves product risk management plan and process FMEA’s for Oral Solid Dosage and incoming materials. Supports the Annual Product Review approval process for all the Oral Solid Dosage, 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) and Certificate of Compliance (COC) for products, according to market requirements. Coordinates priorities to assure timely product releases for different markets. Assures an appropriate lot disposition for all incoming and oral solid dosage materials. 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. 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 incoming 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 incoming area. 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 Oral Solid Dosage and incoming materials. 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. 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.BS in Science (Chemistry, Pharmacy, Microbiology, Biology, Engineering or a related pharmaceutical science). Eight (8) years of progressive managerial experience within the Quality Assurance, Quality Compliance and Quality Control function in a pharmaceutical/health care industry, with at least five (5) years of experience in one of the following areas\: Quality Control laboratory, Aseptic Techniques, Oral Solid Dosage and Medical Devices. 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. In depth scientific knowledge related to analytical and chemical science. Knowledge in analytical instrumentation. Excellent analytical and problem solving skills. 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. Willing to work irregular hours, weekends and holidays if necessary.