Director of Quality

Director of Quality

Fareva is a third-party manufacturing company and one of the world's leading subcontractors in the Industrial, Household, Cosmetics and Pharmaceuticals field.

We are currently seeking an experienced Director of Quality, to join their team in Richmond, VA.

Job Summary:
Reporting to the site General Manager, the Director of Quality provides strategic leadership and vision for all activities related to Quality Assurance and Quality Control (QA/QC). This role ensures compliance with regulatory requirements and company standards, overseeing product dispositions and managing significant quality issues. The Director is responsible for fostering a culture of regulatory compliance and continuous improvement within the organization.

Key Responsibilities:

Leadership & Organization

• Review, identify and implement changes to technology, people and/or processes to assure compliance with Regulatory and Organizational policies and to maximize process efficiency and conformance.
• Provide direction to managers and teams to promote adherence to Good Manufacturing Practices (cGMP).
• Develop and mentor QA/QC staff, promoting internal and external training opportunities.

Compliance & Quality Assurance

• Ensure site compliance with FDA and global regulatory requirements, as well as company policies.
• Oversee the approval of procedures, investigations, and validation documents to meet regulatory standards.

Business Operations

• Direct QA/QC operations for incoming materials, in-process, and final products.
• Facilitate product launches and represent Quality Operations in various business meetings.

Financial Management

• Manage an operating budget and monitor financial performance to support organizational goals.

Facilities & Technology

• Ensure testing laboratory facilities meet operational needs and regulatory standards.

Decision-Making Authority:

• Final authority on product release decisions and compliance-related actions.
• Determine resource allocation for QA/QC functions and approve change control documentation.

Interpersonal Contacts:

• Collaborate with internal teams including Quality Control, Manufacturing, Regulatory Affairs, and external partners for compliance and issue resolution.

Qualifications:

• Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• Experience: Minimum of 10 years in Quality Operations, with at least 5 years in a managerial role. Strong understanding of QA processes and regulatory compliance.
• Proven expertise in regulatory environments, quality assurance, and leading cross-functional teams.
• Skills: Knowledge of cGMP regulations, risk management, effective communication, and team leadership.

Expectations:

• Uphold company values of quality, integrity, respect, leadership, and collaboration.

Compensation and Benefits:

• Compensation is commensurate with experience
• Comprehensive health/vision/dental insurance, company paid life and accidental death insurance
• 401(k) plan match of 4.5% with immediate vesting,
• Generous employee referral program,
• Paid vacation annually, paid holidays annually,
• Manufacturing employees also receive company paid work shoes, uniforms/lab coats and prescription safety eyeglasses.