Quality & Compliance Manager Job

Division:  Oxygenes & Derivatives       

Location: Memphis

Title: Quality& Compliance Manager

Situation in Organization

This position reports to the Plant Manager. One direct report and three indirect reports.

Job Summary 

The Quality and Compliance Manager oversees the overall quality of Hydrogen Peroxide. Due to the reactive nature of Hydrogen Peroxide, product quality is a leading indicator of product safety at the plant, in storage, during transport, and for the customer. The Manager ensures that the plant maintains compliance with all FDA (drug and food), ISO, and AIMS (Arkema Integrated Management System) requirements and manages customer satisfaction, product improvements and new product introduction. The Quality and Compliance Manager is a critical interface with Electronics customers providing analysis of product quality, implications of process changes, and occasionally developing analytical methods as quality requirements increase. The Quality and Compliance Manager role includes all responsibilities of the Lab Manager, the Food Defense/Safety Team Leader, and the ISO Management Representative.

Key Activities and Responsibilities

Quality Responsibilities (65%):

• Oversees plant laboratory and provides support to daily operation of the production units.
• Supports new customer qualification, completes customer surveys.
• Implements new products in the document management system.
• Review/revises procedures in the document management system.
• Controls product and raw material specifications.
• Develops new test methods, as necessary, or works with KoP Analytical Services to develop methods.
• Investigates and resolves quality incidents and customer complaints including root cause analysis investigations and cross-functional team facilitation as needed.
• Provides regular detailed Statistical Process Control data, and interpretation of deviations to customers. Works together with KoP Business Management to provide responsive, data-driven, analysis of product quality for the customer.
• Responds to customer inquiries through customer service or the sales team.
• Develops and maintains API (Active Pharmaceutical Ingredient) product validation documentation.
• Ensures sampling schedules are maintained.
• Manages internal quality audit program including performing Supplier Evaluation.
• Participates in annual Management System Review.
• Reports monthly quality performance (KPIs).
• Develops strategy for the lab equipment performance and reliability.
• Reviews MOCs impacting quality, provides guidance and feedback to other disciplines to ensure ongoing compliance to ISO and cGMP standards.

Compliance Responsibilities (25%)

• Conducts annual ISO/cGMP compliance reviews.
• Ensures compliance to cGMP requirements and all certification requirements for drug/food products.
• Hosts /Manages customer and regulatory (FDA, ISO, NSF, etc.) audits.

Other responsibilities (10%)

• Serve as a coach and mentor to the department personnel.
• Cross-functional team participation.
• Create, deliver, or ensure quality training is completed per requirements.

Minimum Qualifications and Education Required

• 10+ years of experience to include a minimum of 5 years of experience working in a production facility in lab operations and a minimum of 5 years of experience managing Quality Systems.
• Bachelor’s degree in chemical engineering, Chemistry, or related field.
• Experience managing FDA Drug and/or Food Defense Audits, as well as ISO 9001:2015.
• PCQI Certification for FSMA (Food Safety Modernization Act) preferred.
• Experienced in establishing and/or reviewing Quality Agreements.
• ASQ Certification (CQA, Engineer, Pharmaceutical) preferred.
• Knowledgeable in Statistical Process Control.

Competencies -Knowledge Skills & Abilities (KSAs)

• Must be able to multi-task and efficiently operate in a demanding work environment.
• Must have strong organizational, interpersonal and communication skills.
• High level of detail and accuracy required.
• Must possess high functional and/or technical knowledge and skills in areas of responsibility.

HES Requirement

• Ensures the laboratory area is a safe working environment and lab personnel are aware of and adhere to all safety rules.
• Ensures compliance of regulatory and plant safety and environmental requirements with special emphasis on Process Safety Management (PSM).
• Ensures all HES training, standards, policies, and procedures are followed.
• Supports the site HES policy and complies with all regulatory and internal requirements
• Participates in HES activities provided by site management and Arkema Inc. (e.g., Behavioral Base Safety, SafeStart, etc.)
• Ability to interpret/translate process changes to analytical results.
• Supports and promotes the reporting of all health, safety, environmental, near-miss, accident or injury incidents

Physical Demands/Working Conditions

• This position works mainly in an office atmosphere but is required to periodically audit process and laboratory areas.

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