Associate Director, Computer Systems Validation

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The Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) supports the activities and personnel associated with design, development, delivery, validation, maintenance and support of GMP computerized systems at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The individual supports multiple projects and ongoing work activities of low to moderate complexity to ensure compliance to regulatory requirements. The individual directly supervises contract and/or full-time staff to facilitate the completion of departmental deliverables. The incumbent is responsible to author, maintain and manage the System Development Life Cycle for Qualification of Equipment and Validation of Systems. The incumbent will provide direct leadership and oversight over the Compliance Team responsible for the Historical Performance Review.

Shift Available:

• Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.

Responsibilities:

• Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Advanced understanding of change controls, investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Strong multi-tasking ability. Ability to effectively manage multiple CSV projects, initiatives and activities simultaneously. Excels at meeting objective-oriented schedules and timelines.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Ability to create and analyze meaningful metrics.

Knowledge & Skills:

• Thorough knowledge of cGMP in the pharmaceutical industry.
• Advanced computer skills and demonstrated knowledge of validating computer systems used in the pharmaceutical industry
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

​Management Responsibilities:

• Team management.
• Interview and hire internal and / or external personnel to fill necessary roles.
• Provide direction to internal and external team members.
• Set individual and team goals.
• Ensure team members are appropriately trained for duties being performed.
• Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
• Ensure the team is in full compliance with local, site and global BMS policies and procedures.
• Ensure the team is properly staffed and is technically competent to support the various equipment technologies and groups.

Commissioning, Qualification and Validation Activities:

• Manage and allocate resources responsible for teams performing CSV activities of laboratory and manufacturing computerized systems and/or changes to existing computerized systems.
• Responsible for setting direction and maintaining consistency among global and sites computer systems validation approach and deliverables within ECQ responsibility.
• Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform technical reviews of validation deliverables.
• Develop technical support manuals and provide technical input to address system troubleshooting and administration pre and post system release.
• Build and manage a team able to quickly learn and configure new applications, system architecture, and instrumentation with or without vendor assistance and training. Must be familiar with different modes of communication between computer and instrumentation it interacts with.
• Be able to identify regulatory gaps and provide suitable technical and/or procedural mitigations. Address technical and compliance challenges in all phases of the System Validation Lifecycle; research, test, and generate solutions and mitigations.
• Perform 21 CFR Part 11 and system risk assessments.
• Define the needs, benefits, and technical strategy within the project life-cycle and overall processes.
• Ensure resources performing CSV activities are knowledgeable of and in tune with latest industry regulations and initiatives.
• Provide input and guidance for change strategy, risk assessment, testing and compliance gaps with direct ownership of program Continuous Improvement efforts.

Promotes and provides excellent customer service and support:

• Provides technical support and guidance on equipment and computer systems qualification and validations issues.
• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

Regulatory Responsibilities:

• Ensure computerized standalone systems are implemented and maintained in compliance with regulatory requirements.
• May serve as subject matter expert during an internal audit or external regulatory inspection.

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Basic Requirements:

• BS in Computer Engineering or Computer Science related discipline preferred.
• Minimum of 10 years’ experience in a cGMP environment in the pharmaceutical industry.
• Minimum of 8 years’ experience performing/supporting pharmaceutical computer systems validation on pharmaceutical equipment or equipment systems.
• Minimum of 7 years’ experience with direct people leadership.
• Minimum of 8 years' experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.

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With 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 a supportive culture, promoting global participation 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 Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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