Associate Director Quality Compliance (R1558497-en-us)
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.
Associate Director, Quality Systems
The Associate Director, Quality Compliance at the Summit, NJ Cell Therapy Manufacturing site is responsible for all site Compliance activities including the management of the Internal Program, preparing for organizing, and leading inspections conducted by global Health Authorities, and health authority notifications, and Product escalations management.
Incumbent will lead the Inspection Readiness team supporting operational strategies and direction for site inspections. In addition, the Associate Director Quality Compliance will coordinates S12 responses to regulatory inspections; shares best practices and lessons learned following inspections; and works with department leaders to build an inspection readiness capability across the organization.
Associate Director, Quality Compliance is also responsible for the formulation of appropriate audit programs for S12, 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 incumbent will be responsible for leading site compliance activities involving health authorities, including evaluating significant quality events, leading fact-finding meetings for significant quality events, communicating status of significant quality events to the Senior Leadership team and authoring compliance reports to health agencies (Biological Product Deviation Reports (BPDRs) and Product Defect Notifications and Recalls). In addition, the incumbent will lead and coordinate critical compliance activities within S12 – including gap assessments, commitments, and responses to audit and inspection findings – and ensure any quality risks identified are proactively mitigated.
In addition, the Associate Director Quality Compliance, CAR T will provide regulatory insight and direction to the site on external intelligence of regulatory trends, and emerging and changing regulations. The incumbent must have excellent written and effective communication and presentation skills, be proficient in project management, and be a flexible individual to work in a fast-paced environment.
The Associate Director Quality Compliance is also responsible for managing and motivating team members, building trust, and cultivating a collaborative environment.
This position is working closely with the S12 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
- Must have expert cGMP, Quality, and in-depth risk management knowledge, particularly in cGMP Quality Systems
- Must be able to interact with and influence multidiscipline departments and CTDO sites
- Must be able to effectively prepare reports with high level of precision, communicate data analysis to management and others within group with clarity and accuracy and provide guidance to others in technical interpretation of data
- Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and mitigate unfavorable quality systems trends
- Demonstrated excellence in written and verbal communication
- Must be able to conceptualize broad impact of Quality Compliance on site or Quality initiatives and recognize broad Quality issues
- Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking
- Must be skilled in coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation
- Must possess an independent mindset and tenacity
- Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; emerging as a leader
- Demonstrated skills in designing and implementing electronic Quality systems and processes
- Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications
- Requires minimal direction to completes 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
EDUCATION AND EXPERIENCE:
- Relevant college or university degree required
- Minimum 7-10 years relevant cGMP Quality work experience and minimum 5 years of leadership experience
- Equivalent combination of education and experience acceptable
DUTIES AND RESPONSIBILITIES:
- Provide leadership and oversight during Health Authority inspections.
- Establish and maintain inspection management processes and procedures.
- Develop inspection readiness training for subject matter experts, inspection support team, and all site personnel.
- Responsible for providing direction and oversight of the site internal audit program.
- Establish and maintain audit processes and procedures for GMP audit function.
- Effectively establishes and manages the Internal Audit schedule.
- Identify new risks that may not be accounted for in the original audit plan and make any necessary adjustments to mitigate the site’s risk.
- Responsible for developing a training program for auditor qualification.
- Manage performance of audit team during audit engagements.
- Work collaboratively with other sites to ensure consistency in auditing processes.
- Create employee development plans, and oversight of functional area to assure adequate staffing.
- Lead the development and execution of the Site Inspection Readiness Plan that proactively prepares S12 Cell Therapy for Health Authority inspections.
- Initiate the Gap Assessment and/or Mock inspection in support of the PLI readiness.
- Maintain and coordinate inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials for inspections.
- Build and implement tools to improve inspection readiness at the site.
- Identify trends in recent regulatory inspections and translate this to recommendations to improve site readiness.
- Collaborate with Regulatory Compliance team to close gaps and improve inspection readiness capabilities.
- Responsible for defining the Inspection Support team and process that will support all regulatory inspections.
- Lead practices and recommend improvements to ensure S12 is inspection-ready at all times.\
- Ensure processes and procedures associated with Internal Audits are properly implemented.
- Develop risk-based audit planning focusing on patients, and adherence to all policies, procedures and regulations applicable to CAR T products.
- Meet with area leads, audit team and/or SMEs to refine the scope and depth of the audit agenda.
- Lead the execution and conduct of the audit.
- Ensure that findings are identified, evidence is collected where possible, all potential critical findings are immediately identified, and audit expectations and next steps are identified.
- Escalate potentially critical observations to the Site Quality Head.
- Maintain a comprehensive system for recording all audit plans, findings, reports, and follow-up audits.
- Provide critical review of internal audit findings and audit reports 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.
- 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.
- Leads the Summit West (S12) Compliance team in the identification of Significant Events that may require a Notification to Management (NTM). Significant events are events that may impact quality of distributed product, disruption or significant delays in shipment to patients (e.g. Drug Shortage), market or field complaints deemed significant, and significant compliance events where Health Authority (HA) Notification is likely.
- Leads / Hosts Fact Finding meetings on behalf of S12 manufacturing for any Significant Events, including hosting the meeting, solving issues of significance, proposing a path forward, issuing minutes and ensuring all documentation is recorded in the Quality Management System.
- Oversee timely submission of compliance reports to regulatory agencies, including, for example, Biological Product Deviation Reports to FDA (BPDRs), Product Defect Notifications to EMA or Drug Shortage Notifications.
- Communicates to site Senior Leadership Team regarding status of resolution, and interfaces with site external functions to drive resolution (e.g. Supplier Quality, Medical Affairs, Patient Safety, Regulatory Affairs, Global Quality Systems, etc.).
- Partners with Quality, Medical Affairs and Patient Safety to ensure completion of Integrated Health Hazard Assessments (IHHAs), when necessary.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.