Senior Manager, GxP IT Quality Assurance & E-Compliance

Bristol Myers Squibb • New Brunswick, NJ

1d • Hybrid

About The Position

The position is in the Corporate Quality / IT Quality & Data Integrity department and is responsible for providing oversight for the management of Computer System Validation, electronic records and/or electronic signatures in compliance with world-wide health authority regulations.

Requirements

• Strong Knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (E.g., GxP, 21 CFR Part 11)
• In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls
• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required.
• Excellent analytical, interpersonal and communication skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
• Able to work effectively with multicultural workforce.
• Excellent team player attitude.
• Bachelor’s degree in Computer Science, Information Technology, Life Science or a related field
• Minimum of 5-7 years’ experience providing quality oversight for the development, testing, implementation, and validation of computerized systems used by pharmaceutical companies.

Nice To Haves

• Previous experience in risk-based approach to computerized system validation a plus.
• Understanding of quality risk-management concepts (ICH Q9) preferred
• Experience with quality management systems preferred.
• Experience with HP ALM preferred.
• Advanced degree preferred.

Responsibilities

• Provide computer system validation and software development oversight to assure regulatory compliance across the end-to-end product lifecycle (GPS and R&D) to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.
• Carries out functions of IT-QA as directed including but not limited to: Review and approval of key computer system validation life cycle (VLC) deliverables.
• Oversight of key software development life cycle (SDLC) process such as problem, incident, change, release, etc.
• Ensure adequate and timely regulatory compliance support.
• Report on key metrics across the tower.
• Provide active support during internal audits, regulatory agency and third-party inspections.
• Research new technologies, understand existing processes, and reference recognized standards and frameworks.
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
• Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.
• Identify opportunities for continuous improvement.
• Adherence to BMS core behaviors

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior