Sr. Manager, Quality Assurance

Overview

Develops, implements, and maintains the activities of quality assurance systems. Oversees the Batch Records review and releases and implementation of standards, methods, and procedures for the in-line and/or off-line product attributes inspection/evaluation. Makes recommendations for corrective actions necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standardsand satisfy good manufacturing practices regulations.

Responsibilities

Specific 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; partnering with human resources on employee matters.• 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. 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 associate 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.• Interacts 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.• Ensures 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.• Plan, administer, lead and manage Audit program including internal and external audits, as well as regulatory agencies • Oversite of document control systems and programs, ensure compliance and oversite of all QMS• Provide guidance for GMP quality and support production operations. • Other duties as assigned. General Responsibilities• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation. • Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.• Performs such individual assignments as management may direct.

Qualifications

Education, Experience, and Licenses:• 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 with 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.• Professional Quality discipline certifications (CQMOE, CQE, CQA, RAC,) desired• Excellent verbal and written communications and presentations skills, including effectiveness in conducting or participating in meetings, speaking before audiences, or providing training.• Strong interpersonal skillsKnowledge, Skills, and Abilities• Excellent communication and interpersonal skills. • Strong negotiation and problem-solving abilities. • Proficiency in CRM software and Microsoft Office suite. • Attention to detail and organizational skills. • Comprehensive understanding of account management principles and practices. • Familiarity with the retail industry and knowledge of key players and