Senior Manager, Quality Assurance Sterile Operations
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
*** 3rd. Shift - Monday to Friday 10pm.- 6 am.***
EDUCATION AND KNOWLEDGE:
BS in Natural Science (Chemistry, Pharmacy, Microbiology, Biology, Engineering or a related pharmaceutical science) with
five (5) years of progressive managerial experience within the quality assurance function of the pharmaceutical/health care industry and regulatory agencies, and 5 years of experience in one of the following areas: aseptic filling and finishing for liquid and lyophilized products, packaging and medical devices. With emphasis on the support to laboratories, engineering and warehouse; or
Master Degree or PhD in Sciences or Engineering with three (3) years of experience in a quality function within a pharmaceutical / health care industry, with two (2) years of direct / indirect supervisory or managerial experience and experience in one of the following areas: aseptic filling and finishing for liquid and lyophilized products, oral solid dosage and medical devices. With emphasis on the support to laboratories, engineering and warehouse.
Ability to develop and apply BMS’s operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas.
Proficient in cGMP’s and FDA / EMA regulations and requirements.
Experience in containment technologies.
Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions.
Excellent verbal, written and presentation skills.
Must be innovative and creative and utilize all available resources.
Working knowledge in PC’s and electronic tools.
Excellent communication skills in both English and Spanish.
MAJOR DUTIES AND RESPONSIBILITIES:
Ensures quality assurance functions are aligned to support the site business units.
Reviews and approves product / processes related documentation such as: Validations, SOP’s, etc. Provides quality support to the business unit to optimize compliance and efficiency.
Assures the resolution of products and process issues associated to Quality Events.
Provides guidance to the site Change Control activities to assure they complies with all regulatory requirements.
Supports the QC/QA efforts during the transference and validations of parenteral products at the site from the areas of support.
Supports the site audit readiness activities related to all support areas at the site.
Approves product risk management plan and process FMEA’s for support areas products.
Supports the Annual Product Review approval process for all the support areas, and recommends next steps and/or corrective actions based on trends.
Ensures that Corporate Guidelines/Policies are established within the Technical Operations Corporate framework, and are effectively implemented and monitored and assures that the manufacturing and packaging procedures are properly followed and adequate for their use.
Writes, reviews and implements departmental procedures to update them with current practices and Regulatory requirements.
Supports departmental budget preparation activities.
Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.
Supports all site Initiatives in addition to the product transfer initiatives and any other assignments based on business needs.
Ensures there are effective systems for the maintenance and calibration critical equipment and approves calibration requests.
Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
Reviews and approves all process and reports, change control documentation, investigation reports related to the support areas, and Annual Product Quality Review (APQR’s) elements.
Reviews supporting data for compliance with cGMP documentation practices.
Verifies compliance with BMS Policies and Guidelines.
Participates as quality representative or liaison in site projects
Supports Process/Manufacturing decisions during audits with regulatory agencies.
Performs Quality Assurance Oversight to all support areas.
Performs review and approval of investigations and CAPA’s management systems
Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
Verifies consistency with other site procedures and/or specifications.
Approves Corrective and Preventive actions (CAPA’s) and prepares CAPA Effectiveness report.
Evaluates and approve critical area drawings.
Serves as a liaison with internal and external customers.
Ensures the designation and monitoring of storage conditions for quarantine materials and products.
Ensures that an effective system for returns and salvages that include assessment, investigation and disposition is in place.
Prepares site Key Performance and trending metrics.
Participates in the Material Review Board.
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.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.