DIRECTOR QUALITY OPERATIONS
The Site Director, Quality Operations directs and develops the Quality operation of the Manati site ensuring compliance with Company Directives and Government Regulations; and, to lead the site's interface with worldwide regulatory authorities governing the manufacture of Biologic Drug Product. This position ensures 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, Company Directives and Government Regulations to avoid costly recalls or other regulatory sanctions. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. This position ensures quality and compliance oversight of new product introduced to the site and or new facility.
Major Duties and Responsibilities:
Major Duties and Responsibilities:
- Directs all aspects of site quality programs, systems, operations and compliance activities, including, Quality Control, Compliance, Quality Assurance, and Quality Engineering.
- Ensures that appropriate GMP Quality Systems are in place, both through review and approval of procedures and shop floor presence, as required, and that adequate documentation exists to support and drive compliance.
- Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives and verifies consistency with other site procedures and/or specifications.
- Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides leadership accordingly.
- Ensures that deviations from procedures and specifications are investigated, resolved and documented; that 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.
- Lead recalls, market withdrawals, and other regulatory actions when authorized by the Sr. Vice President Worldwide Quality & Compliance or as required by local regulatory agencies.
- Interfaces with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements. Interfaces directly with suppliers and customers, as well as Global Manufacturing and Supply senior management.
- Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues immediately.
- Ensures that all departments have knowledge regarding the roles, responsibilities and authority of the Quality Unit.
- Ensures an effective process/system for disposition of raw materials, API's, packaging and labeling materials and the involvement in the decision for Bulk Drug Substances disposition.
- Chair the site Quality Council in conjunction with the General Manager, and anticipates regulatory trend and establishes systems to adhere to GMP compliance for the site and Company.
- Monitor implementation plans for any new Quality Policies, Directives and associated impact assessments and verify compliance with BMS Policies and Guidelines.
- Ensures that all incoming personnel have adequate training, education, and experience to perform their GMP related job functions effectively.
- Issue/approve/communication of Field Alerts and Biological Drug Product Reports per established timelines.
- Ensure the appropriate information to and obtain the Qualified Person's approval as required by the specific European Union (EU) regulatory authorities is provided.
- Ensure that all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, Investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR's) elements are revised and approval.
- 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.
- Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary. Works on abstract problems across functional areas of the business. Identified and evaluates fundamental issues for major functional areas through assessment of tangible variables.
- Ensures that qualification/calibration of laboratory equipment is conducted following applicable procedures.
- Ensures budgets development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending.
- Direct involvement in securing regulatory filings of a facility or process and supports product submission documentation.
- BS in Natural Science (Microbiology, pharmacy, biology or a related pharmaceutical science). Master 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.
- Proficient in cGMP's and FDA and EMA regulations and requirements.
- QA experience in aseptic filling and finishing areas for liquid, lyophilized products and oral solid dosage.
- Experience in parenteral containment technologies.
- Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management.
- Working knowledge in PC's and electronic tools.
- Excellent and effective communication skills in both English and Spanish.
- Proven ability to lead and motivate employees in all operational areas of the Company.
- Team oriented with excellent interpersonal skills.
- Able to establish and manage priorities according to the business needs.
- 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.