Quality Director

Senior Quality Manager/Director

The Senior Quality Manager/Director at Merit Manufacturing is responsible for maintaining world-class quality systems that ensure lab and manufacturing procedures deliver consistent product quality.

Essential Duties and Responsibilities

• Develop and enforce all company quality policies and train on practices, including cGMP and SOPs.

• Monitor internal processes to proactively improve repeatability and eliminate errors.

• Ensure all testing delivers raw materials, batches and finished products that comply with established standards and specifications.

• Implement customer-required testing and approval procedures in a way that creates satisfaction and trust.

• Provide technical support to the facility and participate in new product activities. Partner with R&D leaders, project teams, regulatory affairs, and manufacturing to integrate quality into every phase of product development. Provide guidance on design controls, validation, and risk management to drive high-quality outcomes.

• Review and understand customer quality agreements; ensure alignment and adherence.

• Manage all external testing with 3rd party labs to deliver lowest cost with the best response time.

• Ensure all laboratory practices and equipment are maintained in a way that generates reliable results.

• Ensure effective and timely execution of internal and external audits; ensure timely resolution.

• Drive continuous improvement in all processes to improve compliance and quality and minimize waste.

• Ensure all non-conformances and complaints are handled efficiently and accurately.

• Lead internal investigations in a thorough and timely manner, and results in positive customer interaction.

• Lead the development of robust corrective actions to permanently resolve root causes of issues affecting quality.

• Report on Quality activities on a regular basis to the Executive team, ensuring accurate and timely reporting of KPIs.

• Oversee the design, implementation, and continuous improvement of the company's Quality Management System (QMS), including documentation control and CAPA (Corrective and Preventive Action).

Supervisory Responsibilities:

• Lead the quality team by creating and communicating a department vision that aligns with company strategies.

• Develop, coach and train the quality team in a way that engages the employees and provides a career path.

• Ensure clarity of role and accountabilities using robust job descriptions and performance reviews.

• Correct, redirect and mentor in a way that causes continual improvement.

Experience Needed:

• Bachelor's or master's degree in Biology, Microbiology, Chemistry, Engineering, or related fields

• 5+ years working in a quality leadership role in a regulated environment.

• Quality assurance experience with a focus on GMPs with substantial operational experience within cosmetics and personal care industry is beneficial.

• In-depth understanding of compliance, quality assurance, quality control and microbiology processes.

• Proven experience managing regulatory requirements and facilitating audits.

• Strong understanding of R&D processes, including design control, validation, risk management, change control and regulatory requirements.

• Strong organization skills, with the ability to work in a fast-paced environment.

• Ability to work, manage projects & team, problem solve and find solutions independently.

• Excellent leadership, communication, and interpersonal skills, with the ability to influence cross-functional teams.

• Demonstrated ability to drive continuous improvement and problem-solving in a fast-paced, innovative environment.

• Strong analytical skills with the ability to interpret complex data and make data-driven decisions.

• Strong communication skills and a proactive team player in collaborating with all key stakeholders across multiple departments and management level.

• Proven track record of developing and implementing quality systems and processes for new product development.

What You Get for Your Hard Work:

Pay: (Depending on Experience Level)

Benefits:

• Healthcare

• Dental

• Flexible Time Off Policy

• Performance Bonus Opportunities

• Year End Bonus Opportunity

• Company events

Equality:

Merit Manufacturing is committed to the full inclusion of all qualified individuals. All qualified applicants will receive consideration for employment without regard for race, religion, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information.