Manager, QA Manufacturing Operations
Bristol-Myers Squibb Company
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 rich in diversity. 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.
Title: Manager, QA Manufacturing Operations
Shift Details: Friday - Sunday, 8 am - 8 pm, eligible for a 5% shift differential
PRINCIPAL OBJECTIVE OF THE POSITION:
Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
MAJOR DUTIES AND RESPONSIBILITIES
- Quality Floor support of complex Manufacturing activities across LSCC and SUF manufacturing areas
- Provide Quality support for complex documentation revisions
- Provides oversight of the review and approval of changes to master batch records or Syncade recipes.
- Lead or participate in quality forums and governance for batch record review, MBR improvement, change controls and EAC.
- Develop, maintain, and act upon Quality key performance indicators.
- Quality support for area related change controls.
- Assist supervisor with developmental feedback and coaching of Field Team members and contribute to creating a collaborative environment enhances unit performance and integration across site departments.
- Reviews, approves and provides guidance for quality master data and NMR requests.
- Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
- Provide Quality review and approval of investigation records and CAPA, records including potential impact/RCA investigations
- Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
- May act as delegate for QA Operations Senior Manager for departmental meetings, projects, and tasks.
- May perform Routine Field QA activities as overflow, MBR review, Floor Support Activities, including alarm review, logbook review, etc.
- Ensures continuity of QA coverage during weekend operations
KNOWLEDGE AND SKILL
- 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 preferred of 6-8+ years experience in biopharmaceutical industry, with 2 years in a quality function preferred.
- Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of electronic systems including any of the following: SAP, LIMS, QMS, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.
- Knowledge in Operational Excellence and Continuous Improvement is desirable.
- Demonstrated matrix leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills are required.
- Well practiced in exercising sound judgment in decision-making.
- Experience where one was required to work in a team-based environment with a diverse group of people.
Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff, as they conduct record reviews and respond to events occurring during day to day operations.
Work is performed in a modern office environment and requires extensive computer work. Additionally, work is performed in state-of-the-art large-scale cell culture manufacturing facility, as well as support GMP areas, with environmental classified areas requiring appropriate personal protective equipment (PPE) and potential exposure to chemical hazards, pressurized gases, and hot surfaces.
Weekend work is required as position is supporting Friday through Sunday
Exercises judgment with in generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates subordinates accordingly. Establishes and recommends changes to policies which affect subordinate organization. Erroneous decisions will result in critical delays in schedule and or unit operations and may jeopardize overall business activities.
Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with establishes policies. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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 an inclusive culture, promoting diversity 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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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