Director of Quality

SUMMARY DESCRIPTION

The Director of Quality will be responsible for overall leadership of the site quality systems, organization and performance results. Responsible for consistently delivering products that meet all customer and compliance quality requirements. Primary contact for customer audits, review and approval of customer quality agreements, customer complaint tracking and investigations. Represents quality on the site leadership team and is a member of the SV Labs Quality leadership team. This role reports to the SV Labs VP of Quality.

PERFORMANCE EXPECTATIONS

• Owns and leads the site’s quality systems and programs
• Maintains awareness of changes in policies, procedures and protocols
• Complies with all 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 the working environment and culture
• Recognizes and resolves problems; troubleshoots procedural misses and gaps, is agile and flexible in identifying and implementing solutions
• Establishes and maintains a cooperative relationship with customers and staff
• Possess strong interpersonal skills with the aptitude to be a team player and leader
• Sets 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
• Interact with fellow employees in a way that promotes a professional and cooperative working environment
• Demonstrates good judgment in handling situations not covered by written or verbal instructions

ESSENTIAL FUNCTIONS

• Overall responsibility for quality organization and site performance (quality KPIs)
• Overall owner of site QMS (effective and efficient operation)
• Ensure quality processes and resources meet business requirements
• Oversee the timely completion of investigations covering nonconforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action, recall program
• Tracking and reporting of environmental and water system(s) monitoring and action items
• Ensure quality requirements are incorporated into all new product launches
• Primary quality contact for all customer complaints, site visits and audits
• Review and approval of customer quality agreements
• Communication to senior management of emerging quality risks and issues
• Lead continuous improvement activities including internal audits
• Building organization capability (training and coaching)
• Document Control and Training Records for the site
• Quality analysis of potential new products for Senior Management
• Participate in or lead teams for special projects as assigned.
• Taking on extra tasks to support the efforts of VP of Quality and company needs

MEETING PARTICIPATION

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

AUTHORITY

This position reports to the SV Labs VP of Quality

SUPERVISORY RESPONSIBILITY

• Quality Control and Quality Assurance teams

CLASSIFICATION

This is a full-time exempt role.

EDUCATION

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

WORK EXPERIENCE

• 5 years’ Quality Experience, preferably in OTC drugs and/or Cosmetics
• 3 years’ Management Experience preferred
• Some laboratory and/or microbiology experience a plus

OTHER QUALIFICATIONS

• Good oral/written communication skills
• Ability to handle multiple projects concurrently
• Can balance daily challenges with longer-term strategic projects
• Bilingual (English and Spanish) a plus