Manager, QA, Quality Engineering and Validation

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.

PURPOSE AND SCOPE OF POSITION:

The Quality Engineering and Validation team at BMS Jump facility is responsible for providing Quality Assurance oversight of environmental, equipment, facility and utility, site automation (site MES, InfoBatch, site LIMs as applicable), and process validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. The Manager position will be instrumental in the compliant and efficient implementation of GMP systems and processes for the BMS Jump site.  The role is responsible for quality oversight and guidance of validation strategy in support of multiple projects and drug product programs. This position will support drug product(s) produced at the BMS Jump site as well as qualification of production methods employing automation and closed system devices.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

Education:

• Bachelors of Science in an engineering discipline

Experience

• 8 year's relevant biopharmaceutical industry experience.
• Additionally, 5-10 years of direct validation responsibilities in GxP Quality, Computer Systems Validation experience
• Experience with validation of enterprise Information Systems, such as ERP (Enterprise Resource Planning), LIMS (Laboratory Information Management Systems), MES (Manufacturing Execution Systems) and EDMS (Electronic Document Management Systems), OSI PI (Plant Information Historian) is required
• Direct experience with providing Quality Engineering guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred.
• Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
• Strong individual contributor with demonstrated ability to work independently.
• Experience in developing/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation strongly preferred.
• Excellent communication, trouble shooting, and problem-solving skills.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

• The role is responsible for quality oversight and guidance of validation strategy in support of multiple projects and drug product programs.
• This position will support drug product(s) produced at Jump as well as qualification of production methods employing automation and closed system devices.
• Review and approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
• Review and Approve Computer System Validation Lifecycle Deliverables such as User Requirements, Specifications, Protocols, Traceability Matrix and Summary Reports.
• Participate in Risk Assessments and complete Risk Analysis deliverables, as appropriate
• Participate in or execute change impact assessments, dry run testing, regression testing, review of test scripts, defect management
• Current pharmaceutical/medical device experience including risk-based approaches, industry best practices and application of guidance (e.g. ICH, PDA, ISPE GAMP 5) will be advantageous in this role.
• Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.).
• Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports.
• Act as Quality Engineering Subject Matter Expert for responsible areas/projects during regulatory inspections.
• Proactively identify and resolve technical and compliance issues/gaps.
• Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.

WORKING CONDITIONS (US Only):

• Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%.
• Sitting at a computer terminal for an extended period of time.
• Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
• Requirement to work in a conference room / meeting environment for moderate periods of time.
• Occasional periods in labs or production area, requiring some level of gowning.
• Light to moderate lifting.
• Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
• Moderate noise i.e. business office with computers, phone, and printers.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Salary : $0