Manager Quality Assurance Operations

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

Purpose and Scope

The QA Operations Manager is responsible for managing Quality Assurance support for manufacturing operations, focusing on aseptic processing, terminal sterilized products, sterility assurance, and contamination control. This role ensures compliance with current Good Manufacturing Practices (cGMP), internal procedures, and regulatory requirements while driving continuous product quality and operational excellence improvement. The QA Operations Manager also serves as the quality representative on cross-functional project teams and collaborates with internal and external alliance partners to support the consistent delivery of safe, high-quality pharmaceutical products.

Essential Duties & Responsibilities

• Provide quality oversight for all sterile manufacturing operations, including aseptic processing, terminally sterilized processes, and related support areas.
• Manage the QA team to provide coverage and decision-making support across a 24/7 manufacturing schedule, including off-shift and weekend operations as needed.
• Ensure the integrity of sterile product manufacturing through robust sterility assurance practices and active support of the site Contamination Control Strategy (CCS).
• Support the site's Contamination Control Strategy (CCS), including routine risk assessments and remediation planning.
• Oversee Quality Oversight program for sterile manufacturing.
• Manage QA review and approval of cGMP documentation, including procedures, protocols, deviations, and change controls.
• Act as a subject matter expert (SME) during regulatory inspections and internal/external audits for quality assurance operations.
• Lead, coach, and develop QA team members to maintain a high-performing, quality-focused, and engaged workforce, to maintain compliance and foster continuous improvement.
• Monitor and report on key quality performance metrics to monitor performance and drive continuous improvement initiatives.
• Collaborate with cross-functional departments (Manufacturing, QC, Engineering, Validation, Regulatory, etc.) to resolve quality-related issues and support new products and product lifecycle management.
• Serve as a QA representative on cross-functional project teams to ensure quality requirements are built into new processes, equipment, and products from the outset.
• Promote a proactive quality culture focused on patient safety, product quality, and regulatory compliance.

Knowledge, Skills & Abilities

• Strong knowledge of cGMP regulations (21 CFR Parts 210/211), FDA Guidance for Aseptic Processing, EU Annex 1, and ICH guidelines.
• Strong technical understanding of aseptic processing, sterilization methods, cleanroom classifications, and contamination control practices
• Understanding of contamination control practices and sterility assurance principles preferred. Experience with quality systems, deviation/investigation management, change control, and CAPA.
• Excellent written and verbal communication skills; capable of presenting quality topics to regulators and senior leadership.
• Ability to analyze complex problems, identify root causes, and drive corrective actions.
• Strong leadership, interpersonal, organizational skills and the ability to influence cross-functional teams.

Core Values

• The Quality Operations Manager 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 discipline required.
• Ten or more years' experience in the pharmaceutical industry in a quality or operations role required.
• 5 years in sterile injectables preferred.
• Four or more years' previous experience in a supervisory role required.

Working Conditions

• Core hours are from 8 AM - 5 PM Monday through Friday, with availability to work extended hours on evenings and/or weekends as necessary.

Compensation and Benefits

• Annual pay range $125,000 - $130,000 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.

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.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)