Associate Director, QC Technical Services
Job
1010 Celgene - Summit (Corp)
Remote
$181,196 Salary, Full-Time
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Job Description
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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.
Read more:
careers.bms.com/working-with-us. Position Summary 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. Duties/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. Qualifications
- 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
EDUCATION AND EXPERIENCE
- University degree required.
- 7-10 years relevant cGMP Quality work experience and minimum 5 years of leadership experience.
Compensation Overview:
Summit West- NJ•
US:
$163,850- $198,543 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis.
Our benefits include:
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.
Eligibility Disclosure:
The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers 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. Supporting People with Disabilities 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. Candidate Rights 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/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1601760
: Associate Director, QC Technical Services Data Privacy Link We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Similar remote jobs
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