Director, Quality Compliance

About the role

As a Director of Quality Compliance, you will lead the development and implementation of quality assurance programs that ensure the highest standards of product safety and regulatory compliance. Reporting directly to the Chief Quality Officer, you will oversee all aspects of quality management, including auditing, testing, and corrective actions.

Responsibilities

• Develop and enforce comprehensive quality assurance policies and procedures.
• Oversee internal audits and external inspections to ensure compliance with industry regulations and company standards.
• Manage corrective action plans to address non-conformities and prevent recurrence.
• Collaborate with cross-functional teams to integrate quality control measures into product development processes.
• Provide guidance and training to employees on quality management systems and best practices.
• Lead the evaluation and improvement of existing quality systems and processes.
• Ensure adherence to all relevant quality standards and regulations.

Requirements

• Bachelor's degree in Quality Management, Engineering, or a related field.
• Minimum 10 years of experience in quality assurance and compliance roles, preferably in pharmaceuticals or medical devices.
• Proven track record of successfully leading quality initiatives and driving continuous improvement.
• Experience with ISO 9001 and/or FDA regulations.
• Strong leadership skills, including the ability to motivate and mentor a diverse team.
• Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization.
• Ability to work independently and manage multiple projects simultaneously.

Qualifications

• Knowledge of quality management systems and their application in various industries.
• Experience with quality risk management and failure mode and effects analysis (FMEA).
• Understanding of regulatory requirements and their impact on product development and manufacturing.
• Proficiency in Microsoft Office Suite and other relevant software tools.

Skills

• Strategic thinking and problem-solving abilities.
• Strong analytical and decision-making skills.
• Excellent organizational and time management skills.
• Ability to prioritize tasks and meet deadlines.
• Effective written and verbal communication skills.

Benefits

• Competitive salary commensurate with experience.
• Health insurance coverage.
• Flexible work schedule.
• Professional development opportunities.
• Employee assistance program.

Pay

The base salary range for this position is $150,000 - $200,000 annually, depending on experience and qualifications.

Schedule

This role is full-time and requires an on-site presence at our Bridgewater, NJ location.