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Bristol-Meyers Squibb, Co.

Sr. Director, Compliance and Quality Operations (R1554163-en-us)

Pharmaceuticals

All

Yearly

No

Manati, Puerto Rico, United States

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.

Education and Required skills:

  • BS in Natural Science (Microbiology, pharmacy, biology or a related pharmaceutical science). Master’s degree preferred.

  • Minimum of 10 (ten) years of progressive managerial experience within the quality control and quality assurance in a biopharmaceutical industry

  • 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 and EMA 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.

  • Proficiency in Quality Compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.

  • Proven record of accomplishment on crisis management and remediation work efforts, prompt to sustainable actions.

  • A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.

  • Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.

  • Has a proven record of accomplishment of delivering results and is action oriented and has work directly with Compliance remediation activities because of regulatory actions.

  • Proven ability to lead and motivate employees in all operational areas of the Company

  • Strong ability to lead through others and driving results with sustain or improved engagement while improving performance.

  • Strategic thinker with the ability to translate strategy into action with short, medium, and long terms plans. Strategic thinker who sees the bigger picture and possesses high business acumen. Understands how the parts impact the whole business (end to end enterprise) and makes the best decisions for the whole organization.

  • Uses judgment to make sound decisions based on information gathered and analyzed.

  • Strong project management capabilities to make plans, organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.

  • Enterprise Mindset. Understands the big picture, beyond their own functional area.

  • Leads within the broader internal and external network and seeks to have impact on organization-wide performance.

  • Embraces complexity but strives for simplicity

  • Shares resources and makes difficult trade-offs to benefit the organization at large. Change Agility

  • Creates a vision for the future by spotting strategic opportunities for breakthrough performance.

  • Translates the case for change into actionable plans for the organization.

  • Demonstrates smart risk-taking and personal resilience when implementing change.

  • Enables others to navigate change with confidence and in sustainable ways. Authentic Leadership

  • Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values.

  • Lives up to their principles and conviction without being rigid or dogmatic.

  • Generates trust by maintaining the highest level of consistency between their words and their actions. Talent Developer

  • Maintains a current and strategic view of talent management, aligned with the organization’s priorities.

  • Understands the needs and characteristics of the organization’s talent and the extent to which it supports the business agenda.

  • Proactively develops talent for the long and short-term, both within and outside their team.

  • Creates a learning environment that ensures people realize their highest potential.

  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

  • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.

  • 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.

  • Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.

  • Adapts to changing work environments, work priorities and organizational needs.

  • 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.

Major and Responsibilities:

  • Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides leadership accordingly.

  • Ensure a timely & effective deployment of the inspection readiness efforts in all aspects of cGMP to assure adherence to an Acceptable status of GMP/Quality/Regulatory Compliance requirements.

  • Leads audits and Health Authority inspection preparation for the Bio-Sterile network, including the assistance in the generation of HA responses and CAPAs. Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System).

  • Coaches, leads, and mentor's Compliance Leaders, training, and development of the necessary skilled professionals to meet business needs.

  • Ensures that deviations from procedures and specifications are investigated, resolved and documented; those corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of deviations and that no materials are released before the completion of the investigation.

  • Works closely on resolution of critical issues that can impact supply continuity of critical medication to patients.

  • Assure that the compliance state of control is maintained by creating and sustaining a high commitment to quality and compliance and works proactively with the different Quality and Operations stakeholders.

  • Interfaces directly 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 regulatory compliance to minimize risks to the Company.

  • Ensures budgets development and the preparation of 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 prevent regulatory sanctions which are consistent with regulatory compliance.

  • Ensures systematic corrective and preventive actions to avoid reoccurrence.

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

  • Ensure that appropriate cGMP Quality System are in place both through review and approval of procedures and shop floor presence as required.

  • Assures that adequate documentation exists to support and drive compliance.

  • Ensure site cGMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ& C Headquarters Polices and Directives.

  • Leads recalls, market withdrawals, and other regulatory actions

  • Leads Data Integrity Program at the site level

  • Ensures site is always inspection ready.

  • Ensure a good health of the investigation and CAPA program.

  • Ensure the completion of Annual Product Quality Review Report elements as established in products / systems schedule.

  • Ensure compliance with BMS Directives, Policies and Global Standard Operating Procedures.

  • Ensure that all process, change control documentation, Investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements are revised and approved.

  • Participates in Fact Finding Investigation and Fact Investigations Review Meetings

  • Supports Process/Manufacturing decisions during audits with regulatory agencies

  • Ensure that an adequate Change Control Program is established.

  • Ensures that there are systems in place to assure that personnel have adequate training, education and experience to perform their GMP related job functions effectively.

  • Ensures the site has a self-inspection program and that all system audits are conducted at a specified frequency.

  • Ensures that all current vendors are qualified and conduct audits of approved Third-Party Manufacturers and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program.

  • Ensure manages the product complaints that include performing complaint investigations in a timely manner, instituting corrective actions where appropriate and identifying product complaint trends.

  • Ensure the effectiveness of the Site Management Review-Quality Council by sponsoring and driving Quality Initiatives that directly impact the Site operations.

  • Ensure Quality Agreements management

  • Manages Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR)

  • Manage Regulatory agencies audits (FDA, DEA, EMEA and International Authorities) which includes lead, escort, responses, contact, updates, and adherence to regulatory commitments.

  • Ensure Licenses renewals

  • Ensure Records Retention program in the functional Department.

  • Supports product submission documentation.

  • Leads site Regulatory Inspections and ensure compliance with the marketing authorization requirements.

  • Monitors implementation plans for any new Quality Policies, Directives, and associated impact assessments.

  • Ensure the completion of Annual Product Quality Review Report elements as established in products / systems schedule.

  • Ensure compliance with BMS Directives, Policies and Global Standard Operating Procedures.

  • Ensure that all process, change control documentation, Investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements are revised and approved.

  • Participates in Fact Finding Investigation and Fact Investigations Review Meetings

  • Supports Process/Manufacturing decisions during audits with regulatory agencies

  • Ensure that an adequate Change Control Program is established.

  • Ensures that there are systems in place to assure that personnel have adequate training, education and experience to perform their GMP related job functions effectively.

  • Ensures the site has a self-inspection program and that all system audits are conducted at a specified frequency.

  • Ensures that all current vendors are qualified and conduct audits of approved Third-Party Manufacturers and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program.

  • Ensure manages the product complaints that include performing complaint investigations in a timely manner, instituting corrective actions where appropriate and identifying product complaint trends.

  • Ensure the effectiveness of the Site Management Review-Quality Council by sponsoring and driving Quality Initiatives that directly impact the Site operations.

  • Ensure Quality Agreements management

  • Manages Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR)

  • Manage Regulatory agencies audits (FDA, DEA, EMEA and International Authorities) which includes lead, escort, responses, contact, updates, and adherence to regulatory commitments.

  • Ensure Licenses renewals

  • Ensure Records Retention program in the functional Department.

  • Supports product submission documentation.

  • Leads site Regulatory Inspections and ensure compliance with the marketing authorization requirements.

  • Monitors implementation plans for any new Quality Policies, Directives, and associated impact assessments.

BMSBL

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 . Visit[Register to View] target="_blank"> [Register to View] 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.