Manager, QA Operations

Job content

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more careers.bms.com/working-with-us.The core mission is to ensure all quality aspects related to manufacturing activities are efficiently and timely managed in compliance with BMS Global Processes and Policies, Standard Operating Procedures, and GMP requirements & regulations.As part of QA Operations, you will act as a key player of the site governance thanks to escalation trough the tier meetings processes, drives performance in his/her scope of responsibilities and actively contributes to continuous improvement initiative.You will be responsible to address the quality topics, take appropriate decisions at the right level. This position is key to facilitate problems resolution in the organization.As our future Manager, QA operations, you will need to be capable of handling complex subjects, in a cross functional environment, from start to finish.In this position, you will also support quality on the floor for manufacturing, packaging, warehousing and QC as well as maintenance and calibrations activities, in collaboration with all team members from partner department. As part of the quality on the floor organization, a capability to solve issues on call is required (following operation schedule in two shifts). The team works closely with the QA Operations release team to achieve the site objective and release the products on time.The Manager is accountable to identify from quality standpoint challenges, risks, delays and is skilled to efficiently report and communicate to Senior Management.The activities include responsibility for execution of the main following processes deviation and CAPA, change control handling, QA oversight of validation and qualification activities, projects representative and process optimization. Additional tasks are batch record review, risk assessments, as well as the support of health authorities’ inspections and corporate audits.COMPETENCIES

• Bachelor’s / Master’s degree in Pharmacy, Chemistry, Biology or equivalent degree/experience in a relevant discipline.
• At least 5 years Quality (QA/QC/Compliance) experience in a pharmaceutical/ Biotechnological company. Experience with quality management system operation and improvement.
• Proven leadership skills empowerment, problem solving, active listener, solution oriented.
• Proven ability to coach other team members and provide guidance.
• Works independently, authority to make decisions.
• Excellent interpersonal, collaborative and organizational skills.
• Excellent communication skills. Ability to communicate (French and English) effectively throughout the organization, internally and externally, with the teams, peers and upper management.
• Thorough understanding and practical application of cGMPs and regulatory requirements (Swiss, FDA, EU,…).
• Very good understanding of solid oral dosage forms manufacturing, packaging, testing, QC , warehousing and validation is preferred.
• Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
• Ability to drive continuous improvement and risk management approach in issue resolution and projects.
• Experience in clinical trial data and batch release process is a plus

Duties And ResponsibilitiesQuality oversight of manufacturing, testing and warehousing operations

• Supports operations in the daily activity and promotes good manufacturing practices, quality culture and right first-time mindset on the shop floor. Take appropriate decisions in collaboration with partner departments to ensure compliance and efficiency of operations activities.
• Responsible for quality oversight on the deviation, lab investigation, CAPA, change control, validation and qualification activities related to production, packaging, testing and warehousing activities.
• Ensure thorough investigations, CAPA definition, change control assessment, validation approach considering right first time and risk-based approach, in a timely manner.
• Oversees maintenance interventions on equipment to ensure cGMP compliance of production and testing processes.
• Manages complex tasks, involvement in cross-functional topics including other BMS entities and Corporate.
• Perform batch record review and prepare batch release documentation, on demand to support the batch release team.
• Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.

Leadership - Individual contributor

• Provides adequate coaching and guidance in a matrix environment to ensure team’s members fulfil high quality standard and oversight.
• Ability to influence and motivate positively QA operations team as well as the organization, to ensure QA expectations are understood and met.
• Reinforces and promotes day-to-day collaboration within the organization to continuously improve and raise the performance, aligned with company values and expectations.
• Promotes quality culture in the organization. Influences and impacts other departments.
• Ability to escalate issues, challenges, delays to senior management with clear facts, support need and “solution oriented” mindset.

Compliance

• Identifies process quality and cGMP compliance related issues, interprets the situation and articulates recommendations through efficient communication.
• Supports health authority’s inspections and corporate audits by supporting QA Compliance team in the preparation of inspections and audits. Acts as SME within his/her scope of responsibilities.
• Writes SOPs and makes recommendations for SOP revisions at a local and global level.
• Approves procedures and documents, ensure accuracy and Right First-Time review and assessment as SME and as part of the QA approver group.
• Ensures the representation of QA Operations within department and cross-functional project teams according to assignments.

Governance

• Supports QA Operations leadership team to achieve expected performance and meet quality and business scorecards targets.
• Actively contributes to Quality Assurance meeting (change review board/ investigation review board/ notification to management processes) and continuous improvement effort of definition and implementation of KPIs.
• Actively contributes to Daily Investigation Meeting. When required, acts as lead and/or back-up to drive roles assignment, triage decisions and CAPA and deviations progress.
• Act as back-up for generating and reporting quality metrics, for contributing to site Quality Council with preparation and presentation of deep dive on specific topics.

Batch release

• Supports the Batch Release team
• Batch record and analytical data review of bulk product, semi-finished and finished products and preparation for release, including electronic QA checklist in MES, according to planned dates and market needs.

Deputy role and deputy activitiesThe position acts as deputy of the Senior Manager, QA Operations responsible for quality oversight.If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.