Supervisor Quality Compliance (Onsite)

The Supervisor Quality Compliance is responsible for management and oversight of the Quality Compliance team within the Quality Assurance Unit to ensure the company's adherence to industry regulations, quality standards, and internal policies. This role involves managing compliance-related documentation, analyzing quality metrics to identify areas for improvement, and acting as a liaison with business partners and regulatory agencies. The areas of oversight within this role include Internal Auditing, Inspection Readiness, Regulatory Audits / Inspections, Quality Management Review (QMR) and Quality Review Board (QRB) programs, Annual Product Quality Reports, Field Alert / regulatory notification reporting and the Recall program.

General

• Maintain a culture of candid communication and continuous improvement with a hybrid / remote team.
• Provide coaching and identify education opportunities for team members to stay current on industry standards and trends.
• Participate in all regulatory, third party and customer audits and inspections, and corrective action responses.
• Be an active participant on cross-functional teams, representing the Quality Systems & Compliance department. Support the Manager Quality Compliance in Field Alert reporting or any recall activities, as applicable.
• Drive collaborative cross-functional interactions with local and global quality personnel to identify and implement process improvements.
• Lead standardization of Standard Operating Procedures, leveraging existing Quality Systems within the functional area.
• Interface and support inspections with Regulatory agencies as required representing the company to authorities and regulatory inspectorates.
• Work collaboratively with both internal and external clients and with regulatory agencies to resolve quality issues and maintain GXP compliance.
• Perform other duties as required.

Inspection Readiness and Inspection / Audit Management

Quality Compliance

Leadership and Professional Development

Knowledge, Skills & Abilities

Core Values

The Supervisor Quality Compliance is expected to operate within the framework of Tolmar's Core Values :

We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.

We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.

We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.

We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.

We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

Working Conditions

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. A final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Qualifications

Skills

Behaviors

Motivations

Education

Experience

Licenses & Certifications

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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