Supervisor Quality Compliance (Onsite)

Core Hours: Monday - Friday, 8am-5pm

Purpose and Scope

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.

Essential Duties & Responsibilities

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:

• Develop and oversee Audit/Inspection Training for SMEs and audit/inspection participants.
• Drive a culture of inspection readiness within Tolmar and ensure periodic walk-throughs of the manufacturing and support areas occur.
• Own the Audit Management system in the Electronic Quality Management System and Inspection software.
• Manage the GxP inspection readiness program, facilitate the Inspection Readiness Steering Committee meetings, ensure the company is prepared for inspections and audits, and manage the Inspection Readiness budget.
• Manage inspections and audits from regulatory authorities and marketing partners and provide follow-up responses for all aspects of the business.
• Participate as a "Front-Room or Back-Room Manager" when applicable, and Subject Matter Expert to ensure accurate, timely production of documents provided to support regulatory inspections.
• Maintain accurate and up-to-date records of quality-related activities, including audits, inspections, and CAPA investigations.
• Conduct internal audits to ensure compliance with quality procedures and identify areas for improvement.
• Manage inspection/audit observations and implement CAPA processes to address quality issues and prevent recurrence.
• Manage the internal audit assessment and approval system, including the establishment of the scheduled audits each year based on risk and budgetary guidelines for internal audits.
• Support planning and execution of Internal Quality compliance audits
• Own and manage the preparation and submission of prepared audit reports and inspection responses detailing deficiencies found during audits and provide follow-up assessments to CAPA actions taken.
• Serve as a primary point of contact for regulatory agencies, managing responses to inspections, and staying current on changes to regulations.
• Develop and deliver training programs to employees on compliance requirements and foster a culture of quality awareness and inspection readiness.
• Perform risk assessments and develop strategies to manage potential compliance issues.
• Investigate compliance violations, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
• Ensure that audit responses are timely and compliant, the support team to facilitate an audit is defined, and SOPs are established in alignment with applicable global regulations and industry trends for Quality Audits to ensure a robust auditing program is established and maintained.
• Work directly with affiliates and distributors to ensure that regulatory inspections are managed in accordance with applicable guidelines and responses are submitted in accordance with regulatory requirements.

Quality Compliance:

• Facilitate the QMR process to monitor and provide oversight of Tolmar's quality systems performance.
• Ensure that phase-appropriate systems are implemented to sustain a consistent level of quality and compliance in all processes.
• Maintain compliance with industry standards and regulatory requirements (e.g., ISO 9001, FDA regulations).
• Responsible and accountable for the Quality Review Board and Quality Management Review program which includes maintaining compliance with the regulation requirements, maintaining meeting charters, owning the process/procedures that govern the meetings, reviewing the presentations prior to the meetings and ensuring the quality board meetings are being held per the process/procedure requirements.
• Manage and compile Quality site metrics and ensure data is presented at the Quality Management Review (QMR) meeting.
• Develop, implement and approve Quality Compliance policies and procedures.
• Responsible for ensuring a compliant and efficient Field Alert/regulatory notification quality system, ensuring that Field Alerts/regulatory notifications are reported within the required timeframes.
• Responsible for ensuring a compliant system is established for recalls, including leadership of mock recalls. Ensure communication of the recall is completed with stakeholders and regulatory agencies per the established recall plan
• Develop and maintain Key Performance Indicators for Internal Auditing, Inspection Readiness and any other related KPI, as necessary, and report through QMR meetings as required or any other management governance meetings.
• Ensure that all quality-related documentation is accurate, up-to-date, and maintained within a system like a QMS.
• Investigate compliance violations, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Deliver Quality support to Affiliate partners to drive a standardized approach to ensuring compliance with relevant GMP and GDP regulations.
• Notify senior leadership of potential negative trends or high compliance risk items that may impact the business and/or compliance profile for the company.
• Perform risk assessments and developing strategies to manage potential compliance issues.
• Assess quality systems to address changing Regulations or industry standards, providing regulatory interpretation and guidance where required.
• Compile pertinent QA metrics for Senior Leadership review; assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Leadership on a periodic basis.
• Manage the Annual Product Quality Review (APQR) process to ensure product quality and regulatory compliance, which includes reviewing product quality metrics, managing related corrective actions, and reporting findings to management.
• Be responsible for the entire APQR process, including approval of the APQR schedule management from new product introductions through discontinuations, analyzing product quality metrics, and identifying trends.

Leadership and Professional Development:

• Invest time in professional development to keep abreast of industry and regulatory trends and best practices in the quality systems arena.
• Manage and lead a high performing Quality team, overseeing daily activities of Quality Compliance staff to ensure job activity deadlines are met.
• Monitor team performance, track progress against goals, and provide regular feedback to team members.
• Participate in the interviewing, hiring, training, and professional development of departmental employees.
• Be an active participant in cross-functional teams, representing the Quality Compliance function.
• Ensure team engagement and performance by quality systems staff by mentoring, training, setting expectations, providing accountability, and performing evaluations.
• Hire and oversee the training of Quality Systems & Compliance employees. Assures that steps are taken to maintain positive morale and continued development.
• Provide or support Good Documentation Practice (GDP) and GMP training to site personnel as requested by Quality management.
• Assign projects and tasks to team members, ensuring clear understanding of objectives, deadlines, and quality standards.
• Conduct performance evaluations for direct reports, providing constructive feedback and identifying areas for growth and development.
• Address performance issues in a timely and professional manner, providing coaching and support as needed.
• Actively supervise and manage the performance of direct reports.

Knowledge, Skills & Abilities

• Knowledgeable of FDA and international regulatory requirements applicable to medical devices and/or pharmaceuticals. Working knowledge in drug or device cGMP and ISO 13485.
• Ability to apply GMP, GDP, GLP regulations and other FDA and international guidelines to all aspects of the position
• Strong Knowledge of Quality Management Systems and Quality Assurance principles.
• Strong analytical and problem-solving abilities to interpret data and identify issues.
• Meticulous attention to detail is crucial for reviewing quality system records and ensuring accuracy.
• Excellent written and verbal communication skills for reporting, correspondence, and training.
• High ethical standards and professional integrity are crucial for making sound decisions.
• Strong interpersonal skills to work effectively with cross-functional teams.
• Understanding of industry-specific regulations and standards.
• Experience conducting internal and external audits.
• Ability to identify, analyze, and resolve quality issues.
• Ability to manage and direct a team and collaborate effectively with other departments.
• Understanding of Risk Management / Risk Assessments.
• Understanding of Data Integrity principles.
• Experience with electronic systems, including EQMS and EDMS systems and ability to create queries and reports from these systems

Core Values

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

• Center on People: 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.
• Are Proactive & Agile: 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.
• Act Ethically: 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.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: 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

• Bachelor's Degree in scientific, engineering or technical discipline.
• Eight (8) or more years of experience working in Quality and/or Compliance in the pharmaceutical industry.
• Five (5) or more years of inspection management and audit experience (e.g., Regulatory or Internal). Certifications may be considered in lieu of experience.
• Three (3) or more years of experience leading or managing the elements of quality systems (deviations/nonconformances, internal audits, training, and annual product quality reviews).
• Certifications such as Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), ASQ Certified Supplier Quality Professional (CSQP), Six Sigma, or other relevant quality certifications preferred.

Working Conditions

• Working conditions are normal for an office environment.
• On-site management of all regulatory inspections and marketing partner audits is required.
• Some domestic/international travel may be required to support audits/inspections, and/or to promote a collaborative team environment.

Compensation and Benefits

• Annual pay range $100,000 - $115,000 depending on experience
• Bonus Eligible
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The 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 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.