Director of Quality

GENERAL RESPONSIBILITIES This position is responsible for contributing to the setting the Quality vision and strategy while promoting a culture of continuous improvement and implementing all requirements to maintain regulatory compliance. Provides leadership, guidance and direction to the Quality staff in support of achieving individual goals, goals of the department, and goals of XGen Pharmaceuticals DJB, Inc. ESSENTIAL DUTIES 1. Supports XGen DJB’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations. 2. Manages assigned activities of the Quality External Manufacturing group with Quality Assurance and personnel as follows: a. Assists in the selection of new personnel as appropriate; b. Makes provisions for the proper orientation and training of new personnel; c. Reviews employee performance on a regularly scheduled basis; d. Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans; e. Coaches and directs personnel to ensure compliance with departmental goals, objectives and budgets; f. Conducts regular meetings and provides guidance and direction to personnel; g. Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing; h. Organizes, schedules, prioritizes and distributes workload among assigned personnel; i. Keeps personnel informed of pertinent policies and procedures affecting the department and/or their jobs; Creates an atmosphere in which upward communication from employees is encouraged; j. Administers personnel policies and procedures as established by company policy; 3. Manages cost center expenses as follows: a. Manages expenses to stay within budget; requests and approves payments depending on level of authority; b. Reviews expenses on a regular basis to ensure proper recording of account expenses; c. Explains variances, exceptions and other impacts that occur between budget and actual expenses; 4. Partners with the VP, Quality to establish quality systems and a mature culture of quality compliance. 5. Notifies VP, Quality of any issue that is or may become a GMP compliance risk 6. Partners with Executive Leadership Team to develop and implement quality strategies to improve and sustain Quality and Compliance from product concept to post-market surveillance and end of product life. 7. Directs QA External Management group responsible for QA operational and compliance activities associated with external third-party business partners and suppliers. Provides interactive guidance and approval, as warranted, on APRs, Investigations, Change Controls, Validations, Stability Protocols, Risk Assessments, Serialization and other operational related records and reports. 8. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. 9. Establishes KPIs and strategically contributes to the growth of the company to lead continuous improvement in processes to ensure the effectiveness and efficiency of Quality Systems. 10. Contributes to the Quality Management meetings to ensure GMP compliance. 11. Participates in regulatory agency inspections internally and at CMO’s/vendors. 12. Assists in responding to regulatory inspection observations and filing deficiencies. 13. Implements and manages department/area specific training program(s) (including GMP, Technical and SOP training). 14. Champions risk-based Quality assessments and promotes internal and external GMP quality. 15. Assists in developing, implementing, and managing the Quality systems and procedures governing the development and commercialization of products, both internally and externally (3rd parties). 16. Ensures that all deviations and complaints are investigated appropriately with active participation in the writing, reviewing and approving associated quality records and reports. 17. Assures that necessary Corrective and Preventive actions are documented and implemented. 18. Works in partnership with Regulatory Affairs to review CMC related documents for ANDA/NDA filings for regulatory compliance and accuracy. 19. Provides guidance and oversight to QA External Manufacturing group, as well as Project Management and Technical Transfer teams. 20. Works in partnership with QA External Managers and QA Compliance to continually monitor supplier performance. 21. Conducts quality business reviews with suppliers. 22. Participates in internal and external company audits to ensure GMP compliance. 23. Maintains Risk Management program. 24. Performs other related duties as assigned or directed. BASIC QUALIFICATIONS Education: Bachelor’s Degree in Science (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering). 15 years minimum in a Quality (QC and QA) environment within the Pharmaceutical industry with experience working with Contract Manufacturing Organizations (CMOs). Master’s Degree preferred; or a minimum of 20 years relevant experience. Minimum of 15 to 20 years relevant experience in a pharmaceutical quality management/ assurance/ control / regulatory compliance environment; Prefer to have working and technical knowledge of key pharmaceutical R&D, manufacturing and packaging processes in Aseptic dosages. Experience with GMP document review, quality auditing, Quality Management System maintenance, Post Market Vigilance for ADE and Complaints, Field Alerts, Product Recall, ANDA CMC document review, Aseptic Manufacturing, CMO management, 21 CFR Part 11, Computerized Systems/Validation. Understand the requirements and procedures related to document control, Quality Assurance, ARD/ QC and FDA regulations/ current published guidances. Ability to perform on tactical and strategic level with hands on involvement in project deliverables. Training (licenses, programs, or certificates): ASQ, Six Sigma or equivalent certification preferred. This is a hybrid on-site/remote work schedule. Skills: Quality Assurance / Quality Control, Regulatory Compliance, Product Development, GMP Compliance, Total Quality Management (TQM), Auditing, Continuous Improvement. Knowledge and experience in Electronic Enterprise Resource Planning (ERP) System/ QM Systems for Inventory Control, electronic QMS, SOPs and Report Writing. Basic/Moderate/Proficient reading, writing, grammar, and mathematics skills Basic/Moderate/Proficient strong interpersonal skills and the ability to work and effectively communicate with cross-functional teams, including use of English language Basic/Moderate/Proficient flexibility, adaptability and ability to prioritize and multi-task to meet critical deadlines Basic/Moderate/Proficient must have excellent technical writing skills and experience in writing and maintaining cGMP documentation Basic/Moderate/Proficient ability to analyze data/information and to assess and resolve complex problems Basic/Moderate/Proficient computer skills including Microsoft Office, Go To/Zoom/Teams Meeting Travel: 25 to 30% Manager Qualifications: Highest Level Managed: Middle/Executive Management Level People Management Tasks: Hire employees, mentor and advise, promote employees, assign and evaluate work, terminate employees, review performance annually Experience: Minimum: 15 Years Proficient: 20 Years Equipment: Operate standard office equipment. OTHER REQUIREMENTS Physical Requirements: Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds