Sr. Manager, Quality Systems

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 working directly with regulators during inspections.

Responsibilities

• 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 and engaged and productive workforce.
• Embrace company-wide policies and procedures. Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect.
• Implement 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.
• 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).
• Ensure 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.
• Ensure the development and maintenance, as appropriate, of data collection and analysis systems including development, rationale, and review of product and process specifications.
• Ensure the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.

Qualifications

• Bachelor’s Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology and/or Biology
• Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired
• Minimum 5-10 years of experience establishing and maintaining quality systems in the Dietary Supplements and/or Pharmaceutical manufacturing industry
• 3+ years in a Supervisory role.
• 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.
• Strong interpersonal skills