Associate Director, QC Technical Services

Bristol Myers Squibb • Summit, NJ

19h • Hybrid

About The Position

Responsible for the Investigations, Deviations, CAPAs, Change Control, and metrics for the Quality Control team. Responsible for coordinating and responding to all internal and external audit, QC training and for implementing and managing Quality Control process improvements in accordance with BMS policies, standards, procedures and Global cGMPs.

Requirements

• Must have expert cGMP, Quality, and in-depth risk management knowledge, particularly in cGMP Quality Systems
• Must be able to interact with and influence cross functional departments
• Must be able to effectively prepare reports with high level of precision, communicate data analysis to management and others within group with clarity and accuracy and provide guidance to others in technical interpretation of data
• Previous experience developing an internal QC audit program
• Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and mitigate unfavorable quality systems trends
• Demonstrated excellence in written and verbal communication
• Must be able to conceptualize broad impact of Quality systems on site or Quality initiatives and recognize broad Quality issues
• Must have experience in root cause analysis and proven track of implementing corrective/preventative actions commensurate with level of Quality and Compliance Risk
• Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.
• Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications.
• Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact team

Responsibilities

• Oversees, supervises, coordinates, and prioritizes daily activities of the Quality Control Compliance organization.
• Assures job objectives are met on a timely basis
• Creates employee development plans, and oversight of functional area to assure adequate staffing.
• Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth.
• Ensures alignment with global Policies, Standards, SOPs, and Work practices associated with Deviations, Investigations, CAPAs, Change Control and Product Complaints
• Develops and Maintains QC Quality Metrics to monitor compliance.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues
• Responsible for developing, managing, and on-boarding requirements for new QC staff.
• Provide SME support during internal and health authority inspections of facility.
• Benchmarks through industry associations, system vendors, etc. to ensure processes and systems are consistent with industry best practices.

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.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees