Manager, QA IT and Equipment 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.

Position:

Manager (IT and E-Systems), QA Engineering

Prerequisites:

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.

Location:

Warren, New Jersey

PURPOSE AND SCOPE OF POSITION:

The Manager is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, and maintaining alignment between business process owners, end users, and other cross-functional areas. The Manager will ensure that IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of BMS’s products.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have GMP, quality, and risk management knowledge.
• Previous experience as a computer system validation/quality assurance/quality control analyst for life sciences company regulated by the FDA is preferred.
• Experience in industry accepted software development and validation life cycle programs and related IT controls
• Understanding quality risk management concepts (ICH Q9) preferred.
• Familiarity with drug development process from discovery through regulatory filing and approval of drug product applications as well as commercial manufacturing processes.
• Ability to support various projects, create and work within internal timelines, and solve problems.
• Must be able to author documents and be able to critically review investigations and reports, interpret results and generate technical conclusions consistent with quality risk management principles.
• Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
• Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes.
• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Routinely recognizes and resolves quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Able to fully interpret complex results and situations with a degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
• Effectively communicates, interacts and represents department in internal and external cross-functional teams.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Work is self-directed
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department's productivity, as well as broadening technical knowledge.
• Able to write and review reports with clarity and brevity.

DUTIES AND RESPONSIBILITIES:

• Provides quality assurance oversight across the end-to-end product lifecycle for software development and validation lifecycle activities with regulated computerized systems to ensure conformance to cGXPs, guidance documents, applicable industry accepted standards and BMS requirements, as applicable.
• Reviews and approves key computer system validation life cycle (VLC) deliverables.
• Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations.
• Ensures adequate and timely quality assurance/regulatory compliance support.
• Research new technologies, understand existing processes and reference recognized standards and frameworks.
• Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.
• Drives use of best-practices during IT systems design, validation, and use.
• Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
• Collaborates with business stakeholders and technical support groups to thoroughly investigate validation or engineering discrepancies.
• Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.
• Reviews and approves documents, change controls, and protocols related to IT systems (site and global).
• Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.
• Supports deviations as needed.
• Manages project activities and ensures appropriate team members are assigned to activities.
• Supports continual alignment of the business process with other business functions and provide effective on-going end user support.
• Develops, maintains and improves key business processes.
• Provide training to appropriate end users as related to enterprise system implementation and updates.
• Drafts, reviews, and edits SOPs, process flow and other business documentation.
• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of data.
• Display Leadership Qualities:
• Create an environment of teamwork, open communication, and a sense of urgency
• Promote a mindset of continuous improvement, problem solving, and prevention
• Build trust and effective relationships with peers and stakeholders

EDUCATION AND EXPERIENCE:

• B.S. degree required.
• Minimum of five years of experience in the pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.

WORKING CONDITIONS: (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.

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.