Senior Specialist, QA Technical Operations

Nashoba Valley Chamber of Commerce; Harvard (MA); On-site; USD 81,000 - 98,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and financial protection

Paid time off

Job summary

Devens site in Massachusetts seeks a Senior Specialist, QA Technical Operations to provide quality oversight across technology transfer, automation, cell bank disposition, validation, and site engineering. You will ensure products meet regulatory standards and support audits with a collaborative cross-functional team.

The role requires a BS in science or related field, 5+ years in regulated environments, and strong knowledge of US/EU cGMP.

Qualifications

• BS in science, engineering, biochemistry or related discipline (preferred).
• Minimum 5 years in a regulated environment with at least 3 years focused on product quality.

Responsibilities

• Supports and provides quality oversight to technology transfer documentation.
• Maintains SOPs for site Quality Assurance programs to ensure high-quality materials.
• Provides floor support to manufacturing processes as needed.
• Reviews and approves Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records.
• Oversees Quality walkthroughs for shutdown and inspection readiness and ensures compliance with procedures.
• Assists in regulatory inspections and participates in internal and external audits.
• Sets performance objectives for QA staff and provides coaching to improve unit performance.
• Reviews investigation records, CAPA records, change management, and automation updates.

Skills

Regulated environment experience

Quality oversight

Team collaboration

Electronic systems knowledge

Education

BS in science/engineering/biochemistry or related

Tools

SAP

LIMS

Infinity (Veeva Vault)

LES

Maximo

Vault

Syncade

Job description

Devens - MA - US

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

Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory audits.

Key Responsibilities

• Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation
• Maintains operating procedures for the site Quality Assurance programs to ensure consistent, high-quality materials are produced.
• Provides floor support to the manufacturing process as needed in a person-in-plant function.
• Performs review and approval of Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records.
• Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures.
• Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
• Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
• Provide Quality review and approval of investigation records, CAPA records, change management, automation changes, and applicable document updates/creations. Provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.

Qualifications & Experience

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 5 years of relevant experience in a regulated environment with at least 3 years focused on product quality.
• Knowledge of biotech bulk and finished product manufacturing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Knowledge of Quality Risk Management principles preferred.
• Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable.
• Experience working in a team-based environment with a diverse group of people.

Compensation Overview

Devens - MA - US: $81,160 - $98,344

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. 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.

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.

• 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 [e-mail]. 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 [e-mail]. 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.

R1603597 : Senior Specialist, QA Technical Operations