Senior Manager GMP Audits Cell Therapy

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.

The Senior Manager GMP Audits CAR T is responsible for managing the Summit West, NJ Cell Therapy Internal Audit (Self-Inspection) Program in accordance with BMS policies, standards, procedures and global cGMPs. In this role, the incumbent will be responsible for the formulation of appropriate audit programs for Summit West assigning and directing staffing resources to complete the audit plan as scheduled, and supporting the Quality Management System to ensure compliance and minimize risk in a regulated Pharmaceutical environment. The Senior Manager GMP Audits CAR T is also responsible for managing and motivating team members, building trust and cultivating a collaborative environment.

As a member of the Quality Assurance Organization, this position is working closely with the Summit West Senior Leadership Team to identify and provide solutions to cGMP related issues and escalate them as appropriate to ensure the site remains in a state of control.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Experience leading and facilitating internal audits at the site level.

Detail-oriented with expert knowledge of cGMP regulations, as well as ATMP regulations, and ability to use judgement and this knowledge to determine appropriate quality systems compliance for site.

Strong leader that has developed high performing, independent and capable teams.

Ability to make independent and objective decisions, and to work with minimal supervision.

Must be able to interact with and influence multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.

Must be able to conceptualize broad impact of Quality systems on site or Quality initiatives and recognize broad Quality issues.

Must possess an independent mindset and tenacity.

Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.

Experience leading teams and cross-functional project teams and driving team performance and results. Contributes highly to departmental performance and quality initiatives; emerging as a leader.

Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact team.

Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.

Ability to work effectively across functional groups and teams to ensure requirements are met.

Excellent verbal and communication skills.

Education and Experience:

Bachelor’s degree in Science required; advanced degree preferred.

Minimum 10 years’ of Quality-related experience in the pharmaceutical industry and a minimum 3 years leading internal GMP audits.

Experience in CAR T or Biologics preferred.

Certified Quality Auditor (e.g. ASQ) preferred.

Thorough understanding of cGMPs and global regulations.

Work independently, yet effectively in a team environment.

Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

Develop risk-based audit planning focusing on patients, and adherence to all policies, procedures and regulations applicable to CAR T products.

Ensure global Policies, Standards, SOPs and Work Practices associated with Internal Audits are properly implemented.

Act as primary link to other CTDO sites to ensure Internal Audits are properly implemented and consistent.

Independently plan, conduct, lead, and/or participate in Internal Audits.

Maintain a comprehensive system for recording all audit plans, findings, reports, and follow-up audits.

Ensure the timely and accurate completion of the Internal Audits as per the annual plan.

Provide critical review of internal audit reports and assess to ensure alignment with the Audit Plan and to ensure that Corrective/Preventive Action (CAPA) plans are adequate to address the findings.

Collaborate with stakeholders to ensure resolution of audit findings identified on-site.

Follow-up and track CAPA plan from Internal Audits through completion.

Support the site to prepare and execute Corporate audits and Health Authority inspections for multiple markets.

Support the site Quality Risk Management Program, Data Integrity Program, and Continuous Improvement projects.

Responsible for effectively multi-tasking and managing priorities in a fast paced and changing environment.

Benchmark through industry associations to ensure processes and systems are consistent with industry best practices.

Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.

Develop, manage and report Quality Metrics for Internal Audits to monitor compliance.

Creates employee development plans, and oversight of functional area to assure adequate staffing.

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com