Senior Specialist Quality Assurance

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist QA (CMO) position is an individual contributor role responsible for supporting Supplier Qualification activities and QA oversight of CMO viral vector manufacturing operations in accordance with business agreements and international regulatory and industry standards. In addition, this role will provide Quality oversight to BMS Development Operations team involved with Viral Vector Volume Determination.?

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:


Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.

Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.

Must provide guidance and communication to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.

Must be action-oriented and customer-focused and skilled in building relationships, problem solving, conflict management, planning and organizing, influencing others, and analytical thinking.

Must possess an independent mindset and tenacity.

Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

Routinely recognizes Quality issues and takes on role as problem solver.

Capable of providing input within the department and cross functional teams.

Able to prepare written communications and communicate problems to management with clarity and accuracy.

Able to write and review reports with clarity and brevity.

Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Knowledge of US and global cGMP requirements.

Understanding of aseptic manufacturing processes.

Excellent verbal and written communication skills.


DUTIES AND RESPONSIBILITIES:


Partner closely with Celgene?s External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners.

Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.

Effectively communicate issues, risks and proposed solutions within the organization.

Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.

Provide communication, support, and guidance to manufacturing partners and within the QA CMO Vector team.

Develops and implements policies and procedures for CMO compliance; including development of Quality Agreements, Quality Business Processes, Product Disposition and Quality Event Resolution in accordance with team derived strategy and business realities.

Perform batch record review for internal and external operations as required

Perform logbook issuance, review and reconciliation as applicable (eg. Development Operations)

Support internal and external audits as needed

Create and revise Standard Operating Procedures as needed.

Other duties as assigned.


EDUCATION AND EXPERIENCE:


Bachelor?s degree preferred in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.?

7 years? experience preferred in related industry experience with a minimum of 3 years? experience in quality assurance, quality control, and compliance.

Knowledge of applicable FDA/EMA regulations in the biotechnology industry.

Strong organizational skills, including ability to follow assignments through to completion.

Experience supporting contractor negotiations.

With moderate oversight from manager, think strategically and understand global impact of decisions.

Excellent verbal and written communication skills.

Detail-oriented with demonstrated applications in problem solving.


Preferred Qualifications:


Experience within the Cellular Therapeutics and/or gene-based products.

Experience with Commercial products manufacture, supply and post-approval change management

Experience managing external suppliers and other supply chain issues.


WORKING CONDITIONS: (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Up to 25% travel may be required in support of this role.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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