Senior Manager Quality Assurance

Job Description

• Develops, implements and maintains the activities of quality assurance systems.
• Responsible for managing and accessing standard operating procedures, quality processes, compliance.
• Integrate new regulations into quality management systems.
• Represent the quality management system in audits and work directly with regulators during inspections.
• Manages the tactical execution of short and long-term objectives through the coordination of activities with a direct responsibility for results, including cost, methods, and staffing.
• Provides leadership, coaching and development plans for all directs reports to maintain an engaged and productive workforce; partnering with human resources on employee matters.
• Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
• Establish standard and meaningful objectives and metrics that align to goals, mission and objectives for applicable department/program. Develops and distribute metrics to support the business.
• Reports on key performance indicators associated with program effectiveness.
• Generally, manages department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of cost, methods, and staffing.
• Ensures goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
• Interact frequently with internal departments particularly in problem resolution.
• Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary actions and terminations.
• Remains current with industry standards and best practices to promote activities necessary for evolution of the quality management system.
• Ensure procedures are clearly defined and implemented to fulfill regulatory and business requirements. Identifies areas for continuous improvement of these procedures (best in class).
• Ensures documents are properly maintained, with good documentation practices, for all manufactured and distributed products, quality system processes, and applicable services.
• Keeps up-to-date on new regulations and standards that affect the program.
• Ensures the development and maintenance, as appropriate, of data collection and analysis systems including development, rationale, and review of product and process specifications.
• Ensures the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.

Requirements:

• Bachelor’s Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology and/or Biology
• Minimum 5-10 years of experience establishing and maintaining quality systems in the Dietary Supplements and/or Pharmaceutical manufacturing industry with 3+ years in a Supervisory role.
• Professional quality discipline certifications (CQE, CQA, CQM or RAB) preferred
• Strong knowledge of FDA Quality Systems regulatory requirements and of standards quality assurance practices for manufacturing operations such as 21 CFR 111, 110, 117, 210, 211, ISO9001.
• Excellent verbal and written communications and presentations skills, including effectiveness in conducting or participating in meetings, speaking before audiences, or providing training.