Senior Manager, Quality Assurance

SUMMARY DESCRIPTION

The Senior Quality Manager will maintain quality and regulatory compliance through the development and oversight of appropriate strategies, tactics, and related activities by contributing information and analysis to strategic plans and reviews. This role will be involved in preparing and completing corrective and preventative actions plans, overseeing internal audits, customer complaints, document control, change control, good manufacturing practices, contamination control and analyzing data for trends, under the direction of the Chief Executive Office.

PERFORMANCE EXPECTATIONS

• Manages the companywide quality and regulatory plans, actions and implementation
• Maintains awareness of changes in policies, procedures and protocols
• Lead and participate in companywide compliance efforts, ensure compliance and support all facets of the Quality Management System
• Complies with company policies and procedures

• Manage quality compliance programs to ensure issue resolution and success
• Lead and participate in formal problem solving processes, conduct root cause analysis and corrective action investigations
• Lead all audit preparation activities and participate in regulatory authority audits.

• Adapts to changes or unusual circumstances in a way that promotes cooperation and minimizes disruption in working environment
• Recognizes and resolves problems; troubleshoots malfunctions in procedures and uses alternative methods if available
• Establishes and maintains a cooperative relationship with customers and staff

• Possess strong interpersonal skills with the aptitude to be a team player and leader: setting a professional tone and establishing a cooperative partnership in all departments throughout the company

• Demonstrates effective communication skills by conveying necessary information accurately, listening effectively and asking pertinent questions when clarification is needed
• Interacts with fellow employees in a way that promotes harmonious and cooperative working environment
• Demonstrates good judgment in handling situations not covered by written or verbal instructions
• Coordinates efforts of effective work activities that contribute to company needs

ESSENTIAL FUNCTIONS

• Oversee the internal and external audit program, which includes focus on GMP and regulatory compliance.
• Manage the quality management system within the company to ensure all federal and international standards/regulations are satisfied
• Review quality metrics. Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate necessary quality adjustments.
• Oversee the following investigations: nonconforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action, recall program.
• Ensure all investigations are performed and closed in a timely fashion. Monitor and report adverse events.
• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
• Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
• Advise executive management on external environment and strategic compliance trend impacting business.
• Manage company-wide training initiatives and document control systems.
• Participate in or lead teams for special projects as assigned.
• Taking on extra tasks in order to support the President/CEO needs of the company

MEETING PARTICIPATION

• Quality team meetings as needed
• Production meetings as needed
• Any others as requested.

AUTHORITY

This position reports to the CEO/President of the company.

SUPERVISORY RESPONSIBILITY

• Quality/Regulatory department.

CLASSIFICATION

This is a full-time exempt role.

EDUCATION

• Bachelor’s degree in Chemistry, Biochemistry or a Biological Science preferred

WORK EXPERIENCE

• 5+ years’ Quality and Regulatory Experience
• 3+ years’ Management Experience preferred

• Office and Laboratory work experience preferred

OTHER QUALIFICATIONS

• Good human relations and oral/written communication skills
• Ability to handle multiple projects concurrently