Senior Specialist, Quality Assurance

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.This position is responsible for Quality Assurance (QA), primarily with QA vendor oversight activities including the review of commercial drug substance, bulk and finished drug products, deviation, complaint, change control record management and general compliance tasks and providing a reliable source of information and accurate interpretation of quality, cGMP/ GDP compliance requirements and quality systems, together with maintaining good working relationships with QA departments at contract facilities.Responsibilities

• For the assigned products and area of Global Quality Operations and International Quality Operations:
• Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements. This includes:
• Building and maintaining a good working relationship with the contractor
• Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, logistic incident reports, Out of Specification (OOS) records, processes, methods, procedures, documentation, etc.
• Recommending quality related improvements to the contractor
• Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
• Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
• Manage change control requests. This includes, as necessary:
• Initiating and approval routing of change control requests
• Performing QA evaluation and endorsement/approval
• Review of associated contractor change control requests
• Monitoring progress of related action items
• Escalation of change controls as required
• Process product complaints. This includes, as necessary:
• Providing support for complaint investigations related to external vendors as required
• Approving complaint investigations where required
• Review, edit, negotiate improvements to, and approve contractor documentation, including:
• Process validation protocols and reports
• Transfer validation protocol and reports
• Investigations, Deviations, OOS records
• Lead review of Annual Product Quality Review reports, as necessary. Edit, and negotiate improvements to contractor supplied Annual Product Quality Review reports.
• Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
• Participate in self inspections as appropriate
• Participate in external audits of contractor manufacturers and distributors as assigned
• Ensure logs, databases and files related to the product quality activities are maintained
• Performance of trend reviews and compilation of metrics
• Perform release of shipments and product returns (transfer to saleable stock) as assigned
• For non-product related duties:
• Develop and/or maintain pharmaceutical quality systems, as assigned
• Author and/or revise standard operating procedures and associated work instructions, as assigned
• Review and provide recommendations on policies and standards, as assigned
• Support GMP/GDP site inspections, as assigned
• Maintain compliance with personal training requirements
• Have the authority to issue directives within the area of responsibilities

Required Qualification(s) And Desired Experience

• BSc or equivalent in scientific discipline
• At least 3 years of experience in Quality Assurance in a pharmaceutical company.
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• Experience in the application of pharmaceutical Quality Systems and Quality Assurance including solid knowledge of cGMP, GDP, ICH and other quality guidelines and standards, and ability to interpret and apply them during daily work
• Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
• Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
• In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU, CH and other international markets
• Ability to assess the right balance between business targets and scientific and quality decisions
• Strong analytical and problem solving skills
• Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate
• Good communication and organizational skills
• Project management skills
• Development, organization, and execution of the Pharmaceutical Quality System of BMS within the Global Quality Organization
• Clear presentation and communication skills both, oral and written
• Must have computer proficiency
• Experience working with SAP and electronic Quality/ Document Management Systems

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 with the resources to pursue their goals, both at work and in their personal lives.