Sr. Director Quality Compliance

• 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, 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 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, 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.

Directs the Compliance, Auditing, Quality Systems and Investigations Programs of the site to ensure that all products are manufactured, tested, stored and distributed in accordance with regulatory and company standards, guides, and procedures and meet the requirements of the Domestic and International regulatory agencies. This position also oversees and audits programs to assure compliance with all principles of current Good Manufacturing Practices and to avoid costly recalls or other regulatory sanctions.

This role will support the Compliance Plan Strategy for the site, including reaching a sustainability phase to ensure a high level of cGMP compliance and the safety, efficacy, and quality of internally manufactured commercial Bio/Sterile drug products. This role will be responsible for Inspection Readiness and critical events and must be a level an expert SME in Compliance of Bio Sterile operations.

This role has the accountability to ensure that the Phoenix site is in compliance, inspection ready and the products are manufactured, tested, stored, and distributed in accordance with regulatory and company standards, guides, and procedures and meet the requirements of the Domestic and International Regulatory Agencies. This position also oversees and audits programs to assure compliance with all principles of current Good Manufacturing Practices, Company Directives and Government Regulations to avoid costly recalls or other regulatory sanctions.

BMSBL

#LI-Onsite