Senior Quality Compliance Manager

Job Description

Position Summary

The Senior Manager of Quality Compliance plays a crucial role in maintaining and enhancing the quality standards of the organization. This position is responsible for overseeing the internal audit system, managing external audits conducted by regulatory bodies and customers, overseeing the Corrective and Preventive Action (CAPA) system, managing the facility cleaning crew, and overseeing in-process inspections of finished goods. The role requires a strong leader who can drive continuous improvement initiatives and ensure compliance with industry standards and regulations.

Responsibilities and Essential Duties

Develop, implement, and oversee the internal audit program to ensure compliance with regulatory requirements and company standards.

Schedule and conduct regular internal audits, analyze findings, and prepare detailed reports.

Serve as the primary contact for external audits conducted by regulatory bodies and customers.

Prepare the organization for external audits by ensuring all quality systems and documentation are in order.

Manage audit processes, respond to audit findings, and implement corrective actions as necessary.

Oversee the CAPA system to investigate quality issues, determine root causes, and implement effective corrective and preventive actions.

Monitor the progress of CAPA activities to ensure timely and compliant closure.

Oversee in-process inspections of finished goods to ensure they meet quality standards and specifications.

Collaborate with production teams to address any quality issues identified during inspections.

Ensure inspection processes are documented and records are maintained accurately.

Oversee the facility cleaning crew to ensure that the facility is well maintained at all times.

Technical Skills Required

In-depth knowledge of regulatory requirements, including FDA regulations and GMP standards.

Strong leadership and management skills with the ability to lead cross-functional teams.

Ability to work independently and collaboratively, managing multiple priorities in a dynamic environment.

Excellent communication skills, both oral and written.

Excellent problem-solving and analytical skills with sound decision-making abilities.

Proficiency in quality management systems and software.

Detail-oriented with a strong focus on continuous improvement.

Qualifications

Experience Required

Bachelor’s degree in Quality Management, Engineering, Life Sciences, or a related field.

Minimum of 4 years of experience in leadership role(s) within the pharmaceutical, cosmetic, or related industry.

Proven experience in managing internal and external audits and CAPA systems.

Physical Requirements

Regularly sit, stand, and walk for extended periods of time.

Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.

Physically able to lift 50 pounds periodically.

Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.

Prolonged use of computer screen.Company Description

BMSC is committed to manufacturing personal care products of the highest quality that promote better living. We strive for continuous progress in the research and development of innovative products, while building lasting relationships with our customers. We will build a reputation for reliability, integrity, and honor.

Full-time