At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
The main purpose of the C&Q senior manager is part of the site engineering and maintenance department. This role is responsible for managing processes related to qualification/validation activities.
Primary responsibilities include:
- Laboratory Equipment Qualification,
- Utilities and HVAC Qualification,
- Computerized System Validation.
He Develops and implements a strategic approach to ensure a validated and compliant state of operation for systems and equipment mentioned below. He Leads the validation execution and quality review of all validation documentation, ensuring external regulatory and internal guidelines and requirements are met.
All activities will have to be realized in the strict observance of the regulation cGMPs, FDA, of the hygiene environmental and safety rules.
Key Responsibilities:
- Lead the Validation/Qualification function for the BMS Boudry Manufacturing site and supporting Quality Control laboratories.
- Lead functions within the Validation/Qualification group responsible for installation, operational and performance qualification (IQ/OQ/PQ) of laboratory equipment, qualification of critical process utility systems and validation of computerized system.
- Oversee validation execution for all engineering projects (small to large). Establish Validation/Qualification project plans commensurate with the level of risk and manage the execution of qualification/validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.
- Owns the Site Validation Master Plan for all related Validation/Qualification activities.
- Responsibilities include oversight of Validation/Qualification execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing requalification programs. This individual works in conjunction with Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies.
- Responsible for delivering Validation/Qualification projects under strict deadlines to ensure customer success and bulk drug supply. This includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.
- Manage multiple projects while serving as a point of contact for Validation/Qualification execution projects.
- Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present Validation/Qualification philosophies and strategies to Health Authority inspectors and auditors.
- Works collaboratively with Manufacturing, Global Engineering, Site Engineering Quality control and Quality.
- Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiency.
- Ensure alignment with BMS directives and industry guidelines on Validation/Qualification.
- Develops and manages a high performance team responsible for Validation/Qualification execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.
- Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time.
- Responsible for ensuring all regulatory and GxP compliance items related to Validation/Qualification are satisfied.
- Provide significant regulatory inspection readiness training, coaching and guidance to junior level staff/SMEs in qualification/validation group.
Qualifications
Degree/Certification/Licensure:
- Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience
Experience – Responsibility / Competencies – Knowledge, Skills Abilities
- Minimum 5 years directly relevant experience in Validation/Qualification (Equipment, , HVAC and utilities, computer systems, manufacturing control systems (automation) and laboratory instrumentation in drug substance manufacturing facility preferential.
- Previous managerial experience, which demonstrates proficiency in selection, motivating and retaining a superior team,
- effectively managing personnel issues (workload, priorities,…) and planning and administering financial resources preferred.
- Experience with Health Authority Inspections, External Auditors, Corporate and Internal Auditors presenting qualification/Validation philosophies, strategies and executed testing.
- Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.
- A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
- The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
- Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.
- Knowledge of regulatory qualification/validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
- Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.
- Strong knowledge of critical utility and HVAC systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies
- Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems)
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
- Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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.
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BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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R1607412 : Senior Manager C&Q