Senior Manager, GxP IT Quality Assurance & E-Compliance

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.

What You Will Do

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.

Why It Might Be a Fit

Strong Knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (E.g., GxP, 21 CFR Part 11) is required. Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry is required.

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
• Previous experience in risk-based approach to computerized system validation a plus
• Understanding of quality risk-management concepts (ICH Q9) preferred
• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required
• Experience with quality management systems preferred
• Experience with HP ALM preferred
• 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, Advanced degree preferred
• Minimum of 5-7 years’ experience providing quality oversight for the development, testing, implementation, and validation of computerized systems used by pharmaceutical companies

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
• Paid Time Off
• Flexible time off (unlimited, with manager approval)
• 11 paid national holidays
• 160 hours annual paid vacation for new hires with manager approval
• 11 national holidays
• 3 optional holidays
• 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
• Annual Global Shutdown between Christmas and New Years Day