Supervisor Quality Systems

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

Purpose and Scope

The Supervisor Quality Systems is responsible for supporting timely and effective implementation of all company’s policies, procedures, and activities involved in assuring the quality of manufactured products. This position maintains close working relationships with department management and supervisory personnel in order to meet and maintain product quality, identify, solve and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements. Additionally, this position is responsible for overseeing the implementation and maintenance of a company's Quality Management System (QMS), ensuring compliance with standards, and leading a team to improve quality processes.

Essential Duties & Responsibilities

General:

• Keep abreast of the latest industry standards and best practices in quality management and electronic systems.
• Own and update SOPs and maintain compliance with various governing procedures and policies as they relate to investigations and trend analysis.
• Develop and implement processes, procedures, forms, work instructions and tools related to the implementation of compliance systems. Provide support to Director Quality Systems in project coordination, problem solving, and designing process improvement solutions.
• Participate in all regulatory, third party and customer audits and inspections, and corrective action response. Support Inspection readiness at the site as Quality Systems Subject Matter Expert.
• Perform other related duties as assigned.

Quality Systems:

• Support the overall quality management system, ensuring compliance with regulatory requirements (e.g., FDA, ISO).
• Innovate and enhance processes through research and evaluation, and formulate quality plans to achieve safety, quality, schedule and cost targets.
• Identify and implement improvements to quality systems, including technical complaint and change control processes.
• Assist in reviewing and approving quality-related issues (including customer complaints) through collaboration with other departments.
• Make proactive recommendations and offer/present solutions to the Quality Systems Department Management to improve quality and work efficiency.
• Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
• Manage and maintain corrective action systems for internal and external failures, ensuring efficient and effective problem identification, prioritization and resolution.
• Ensure compliance with relevant SOPs while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each deviation and complaint has on the product, process, and patient health and safety.
• Assess the manufacturing or analytical environment, independently conceive and advise senior management on appropriate corrective/preventative actions designed to mitigate quality deficiencies identified in the investigative process using industry accepted analytical tools.

Change Control:

• Oversee administration of the Change Control systems.
• Coordinate and chair the Change Control Review Board.
• Review and approve change control documentation, ensuring changes are conducted in a thorough and timely basis.
• Process and track change requests, ensuring proper review and approval.
• Communicate changes to affected personnel.
• Maintain records of changes made to documents and processes.
• Update SOPs and maintain compliance with various governing procedures and policies as they relate to investigations, and perform trend analysis.

QA Patient Safety:

• Assist and supervise daily technical complaint operations, reconciliations, and periodic (monthly, quarterly) reporting.
• Maintain the Technical Complaint (TC) System (database) and act as a contact for questions or concerns raised to Tolmar.
• Supervise the evaluation of returned complaint samples and report critical evaluation findings to key personnel.
• Interact with QA Patient Safety Associates and other Tolmar departments for all issues related to TCs.
• Managed the team’s initiation of complaint investigations and assist in coordinating all aspects of investigations through to closure.
• Lead QA Patient Safety team in more complex, long-term improvement projects and initiatives such as SOP creation/updates, database related enhancements, or TC system set up and operations.
• Review and approve complaint trends using information maintained in the TC database and oversee the initiation of investigations where trends indicate.
• Prepare complaint reports and KPI metrics for distribution to senior management.
• Update procedures to meet ISO and cGMP requirements.
• Interact with regulatory bodies to present the TC system during audits and inspections.
• Collaborate with Tolmar departments (e.g., Regulatory, Clinical, QA, and Legal), as needed. Provide Tolmar management with TC related information, as needed.
• Assist with Quality Assurance Agreements (QAA), Safety Data Exchange Agreements (SDEA) Pharmacovigilance Agreements (PVA) development and updates for Market Authorization Holders (MAH), as needed to comply with regulations.
• Confirm ongoing compliance with QAAs, SDEAs and PVAs.
• Participate in Tolmar pharmacovigilance and vendor team meetings as a Tolmar representative.
• Escalate complaint related issues as appropriate with proposed mitigation strategies.
• Coordinate when an adverse event report warrants product quality investigations, as required.
• Incorporate industry-leading, innovative initiatives aimed at improving effectiveness of TC processing and metric generation for both marketed and developing therapies.

Knowledge, Skills & Abilities

• Advanced technical writing skills, procedure and report writing capabilities.
• Strong critical thinking and deductive reasoning skills.
• Strong team player and leader with the ability to work across multiple functions and disciplines.
• Ability to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
• Ability to influence and train others, changing behaviors through coaching and mentoring.
• Ability to interface positively with Regulatory Agencies, vendors and company departments.
• Strong aptitude in computer knowledge (Microsoft Office applications) and computer-based applications. Experience with Veeva strongly preferred.
• Working knowledge in drug or device cGMP and ISO 13485.
• Ability to work under pressure, meet deadlines, and make effective decisions.
• Ability to adapt to changing organizational and operational needs; ability to lead others through change.
• Ability to handle multiple tasks simultaneously.
• Advanced knowledge of QA principles, concepts, systems, industry practices and standards.
• Skill in organization and prioritization, and attention to details.
• Ability to work independently.

Core Values

The Supervisor Quality Systems 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 Science, Engineering or related field required.
• Eight (8) or more years of related experience in CGMP regulated environment required.
• Five (5) or more years in Quality Engineering or other quality systems experience with demonstrated success leading, driving, and/or implementing quality systems in the Medical Device, Pharmaceutical, or Life Science industries.
• Two (2) or more years of experience in a supervisory capacity preferred.
• Experience participating in and/or leading continuous improvement initiatives utilizing lean manufacturing principles such as kaizen events, 5S, visual management, standard work, and value stream mapping preferred.
• Certifications such as Certified Document Controller (CDC), ASQ Certified Quality Engineer (CQE), Six Sigma, or other relevant quality certifications preferred.

Working Conditions

• Working conditions are normal for an office environment. Some overtime and weekends may be necessary.
• This position may be eligible for a Hybrid work arrangement, with an emphasis on being on-site to supervise employees who are not remote.

Compensation and Benefits

• Annual pay range $100,000 - $115,000 depending on experience
• Bonus Eligible
• Benefits information:

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.