Site Director, QA 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

Education and Skills required:

• BS in Natural Science (Chemistry, pharmacy, biology or a related pharmaceutical science). Master degree preferred. Minimum of 10 (ten) years of progressive managerial experience within the quality control function of the pharmaceutical/health care industry and regulatory agencies.

• Extensive knowledge and experience in pharmaceutical/health care operations, manufacturing, pharmaceutical/health care technology, quality control testing and federal/International regulations are essential for appropriate decision making ability and representation to regulatory agencies.

• Understanding of the regulatory environment

• 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 regulations and requirements.

• QA experience in aseptic filling and finishing areas for liquid and lyophilized products.

• 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 and have the ability to deal effectively with all levels of management. Must be innovative and creative and utilize all available resources.

• Working knowledge in PC’s and electronic tools.

• Excellent and effective communication skills in both English and Spanish.

• Proven ability to lead and motivate employees in all operational areas of the Company Team oriented with excellent interpersonal skills.

• Able to switch priorities plus manage more than one case at the time.

• Ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, research oriented individual - but practical, with an ample sense for innovation.

• Effectively manage cultural and operational differences.

Duties and Responsibilities:

• Creates and maintains a high commitment to quality and compliance and works proactively to assure that the state of the industry is maintained.

• Interfaces directly with suppliers, customers, regulatory agencies such as FDA, DEA and foreign regulatory agencies, as well as Technical Operation senior management.

• Reinforces the Bristol-Myers Squibb approach to leadership development, reward and recognition and fostering effective team skills.

• Builds cooperative and supportive working relationships with all Technical Operations Sites in the supply chain on technical, quality or regulatory matters and; maintains positive relationships inside and outside of the Company, e.g. regulatory agencies and BMS business partners and suppliers.

• Foresees how decisions may impact the rest of the organization.

• Assesses benefits and cost of all areas of Quality Assurance and regulatory compliance to minimize risks to the Company.

• Develops budgets, prepares periodic projections of spending against budgets; and manages and controls departmental spending.

• Leads staff to achieve professional growth and to attain established goals, develops remedial actions for staff whose performance does not meet standards and, determines merit salary actions for the staff.

• Implements policies and procedures designed to avoid regulatory sanctions which are consistent with regulatory compliance.

• Ensures adherence to QC/QA procedures, policies and guidelines.

• Implements systematic corrective actions.

• Anticipates regulatory trend and establishes systems to minimize GMP compliance to the site and Company.

BMSBL #LI-Onsite

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.

On-site Protocol
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.

COVID-19 Information
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 adastaffingsupport@bms.com. 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.