Associate Manager, QA Documentation Control

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Title:

Associate Manager, S12 Documentation Control

Direct Manager:

Manager, QA Document Control

Division:

CTDO Quality Assurance

Grade:

D05

Direct Reports:

N/A

Location:

Summit West, S-12

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 Associate Manager is responsible for supervision of Document Control activities in accordance with Celgene policies, standards, procedures and Global cGMPs. Functional responsibilities for the incumbent include supervision of daytime document control activities for Cell Therapy Development and Operations (CTDO); Oversee a QA document control team that will ensure Document Management align with Global and Regional Regulatory requirements. Work proactively to identify and address any document control compliance issues. Manage and motivate team members, build trust and cultivate a collaborative environment. Oversee team responsibilities and maintain a state of compliance.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have advanced GMP, Quality and risk management knowledge;
• Must be able to effectively prepare and convey data analysis to management and others within group with clarity and accuracy;
• Must have broadening technical and scientific knowledge and be able to analyze complete data in areas specific to job function at advanced level;
• Must have strong authorship and be able to critically review reports to address relevant technical or scientific issues;
• Must be able to produce data report with high level of precision and provide guidance to others in technical writing and in interpretation of complex data;
• Must lead communication regarding potential issues cross functionally;
• Must be able to coach team members to bridge knowledge gap;
• Demonstrated skills in designing and implementing quality electronic documentation systems and practices;
• Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications;
• Demonstrated ability to maintain current knowledge of applicable regulations and other regulatory changes.

Education and Experience:

• Relevant college or university degree preferred.
• Minimum 5 years of relevant industry experience, of which 2+ years of Document Control experience, is required.
• Experience with Veeva systems is preferred.
• Strong People Management experience is required.
• Equivalent combination of education and experience acceptable.
• Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).
• An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:

• Ensures staff are properly trained on controlled, approved GMP and Document Control procedures;
• Manages individual development plans for direct reports ;
• Documents employee growth and performance;
• Reviews and approves employee timecards;
• Conducts annual employee performance review with direct reports ;
• Documents and addresses employee corrective actions and performance improvement plans ;
• Relay shift communication to Document Control team;
• Manages Document Control process issues cross functionally;
• Escalates concerns/ issues to Document Control Management;
• Supervise the global electronic GMP/GDP documentation system in compliance with regulatory and BMS requirements;
• Accountable for provision of effective documentation system KPIs, metrics, and proactive issue identification and resolution;
• Ensure that documentation complies with established electronic documentation system standards;
• Provide support during internal and health authority inspections of facilities and CSPs;
• Execute documentation system-related Quality Systems Objectives as assigned;
• Review and approve all new and revised CTDO local site SOPs to ensure compliance with cGMPs;
• Participate in cross-functional teams as subject matter expert for electronic documentation systems.

WORKING CONDITIONS (US Only):

• The incumbent will be working 80% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
• The incumbent will need to have flexibility to work ex Work is performed during the hours of 7am to 3pm, Monday through Friday. 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. Light to moderate lifting may be required, up to 25 lbs. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. Extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

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 based on business needs.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.