Manager, QA & Regulatory Affairs

Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.

At Mesa Labs we offer competitive wages, including potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position.

Base Compensation Range: $119,000 - $148,875/yr
*In addition, you qualify for:

• Annual bonus opportunity of 15% based on company performance
• Annual equity award of $14,000

Outstanding Benefits and Perks
We are proud to offer a variety of benefits that meet the diverse needs of our employees:

• Eligible for benefits the first day of the month after you start
• Tiered Medical, Dental and Vision Insurance options, Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts
• Company paid short term and long-term disability (unless covered by a state disability plan)
• Company paid life insurance and AD&D
• Flexible Time Off Policy
• Paid sick leave of 48 hours per calendar year
• Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws
• 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1
• Employee Wellness and Financial Assistance Resources through Cigna and NY Life
• Nine (9) paid company holidays per year
  

Agena Bioscience® empowers research laboratories worldwide to deliver scalable targeted genomic data. Our open, advanced platform, the MassARRAY® System, provides researchers with insights through a highly multiplexed solution in the areas of mutation profiling, liquid biopsy, pharmacogenetics, and more.

Job Summary

The Manager, Quality Assurance & Regulatory Affairs is responsible for managing day-to-day Quality Assurance and Regulatory Affairs activities to support product quality, regulatory compliance, and effective execution of the Quality Management System (QMS). This role leads a team of quality and/or regulatory professionals, translates department priorities into operational plans, and ensures assigned quality and regulatory programs are executed consistently and effectively. The Manager partners with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and compliance issues, support product lifecycle activities, and drive continuous improvement.

Duties/Responsibilities

• Quality Management Systems & Operations
  • Manage the implementation, maintenance, and ongoing effectiveness of assigned elements of the Quality Management System in accordance with applicable standards, regulations, and company requirements.
  • Translate quality objectives and department priorities into team goals, work plans, and measurable activities.
  • Monitor quality metrics and trends, identify issues, and implement appropriate actions to improve performance.
  • Partner with cross-functional teams to ensure quality requirements are incorporated into product lifecycle and operational activities.

• Regulatory Affairs Support
  • Manage assigned regulatory activities supporting product development, market access, product changes, and lifecycle management.
  • Ensure regulatory activities are completed in accordance with applicable global requirements, standards, and internal procedures.
  • Coordinate regulatory submissions, change notifications, registrations, and communications with regulatory bodies as applicable.
  • Assess regulatory requirements and provide guidance to cross-functional partners on routine and moderately complex regulatory matters.

• Leadership & People Management
  • Lead, coach, and develop Quality Assurance and/or Regulatory Affairs employees, establishing clear priorities, expectations, and accountability.
  • Assign work, monitor progress, and balance team resources to meet operational and project requirements.
  • Conduct performance discussions, support employee development, and address performance concerns in partnership with Human Resources as appropriate.
  • Build team capability through coaching, knowledge sharing, and development opportunities.
  • Foster a culture of quality, compliance, collaboration, and continuous improvement.

• Compliance, Audits & Risk Management
  • Maintain audit and inspection readiness for assigned areas and support internal and external audits, inspections, and regulatory assessments.
  • Coordinate responses to audit observations, nonconformances, and regulatory findings, ensuring actions are completed accurately and on time.
  • Identify quality and compliance risks within assigned areas and escalate significant issues as appropriate.
  • Support implementation of risk mitigation activities and monitor effectiveness.

• Corrective & Preventive Action (CAPA)
  • Manage or support root cause investigations and corrective and preventive action activities for quality and compliance issues.
  • Ensure investigations are appropriately documented, actions address identified causes, and commitments are completed within required timelines.
  • Monitor CAPA effectiveness and identify recurring issues or trends requiring additional action.
  • Partner with cross-functional teams to improve product and process quality and prevent recurrence of quality issues.

• Cross-Functional Collaboration
  • Partner with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and regulatory issues and support business objectives.
  • Provide practical quality and regulatory guidance for new and existing products, processes, and operational changes.
  • Participate in cross-functional projects and ensure quality and regulatory requirements are understood and incorporated into project plans.
  • Communicate significant quality, compliance, and regulatory issues to appropriate stakeholders and management.

• Continuous Improvement & Operational Excellence
  • Lead or support improvement initiatives within assigned quality and regulatory processes using data and established continuous improvement methods.
  • Identify opportunities to improve efficiency, consistency, documentation, and compliance.
  • Implement standardized processes and tools that improve team effectiveness and scalability.
  • Promote continuous improvement and problem-solving within the team.

• Reporting & Communication
  • Prepare and communicate quality and regulatory metrics, trends, risks, and program status to management and cross-functional stakeholders.
  • Analyze data to identify trends, support decisions, and recommend actions within assigned areas.
  • Maintain clear and timely communication regarding quality events, regulatory activities, project status, and emerging risks.

Experience/Education

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline, or equivalent combination of education and experience.
• Typically 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a regulated environment.
• Typically 2-3 years of people leadership, supervisory, team lead, or other demonstrated leadership experience.
• Experience working with cross-functional teams and managing multiple quality or regulatory priorities.

Knowledge and Skillsets Required

• Strong working knowledge of Quality Management Systems and applicable regulatory compliance frameworks.
• Experience with audits, CAPA, nonconformance management, change control, risk management, and related quality processes.
• Working knowledge of regulatory requirements and product lifecycle activities applicable to the business.
• Demonstrated people leadership skills, including coaching, performance management, prioritization, and team development.
• Strong analytical, problem-solving, and decision-making skills with the ability to resolve moderately complex issues and escalate higher-risk matters appropriately.
• Strong communication and influencing skills with the ability to collaborate effectively across functions and organizational levels.
• Ability to translate department objectives into operational plans, priorities, and measurable team results.
• Strong organizational and project management skills with the ability to manage competing priorities and deadlines.

Physical Demands:

• Sitting: Often for extended periods at desks or meetings.
• Standing or walking: Occasionally for meetings, audits, inspections, or office tasks.
• Using computers: Typing and using office equipment.
• Lifting: Light, less than 10 pounds.
• Repetitive motions: Frequent use of keyboard and mouse.

Environmental Conditions:

• Workspace: Climate control (air conditioning or heating) to ensure comfort.
• Lighting: Adjustable lighting to reduce eye strain.
• Noise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary.
• Ergonomics: Workstations with desk and adjustable chairs to support good postures.
• Ventilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building.

Mesa Labs is an Equal Employment Opportunity Employer.

Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law.  Please note that Mesa Labs conducts criminal background checks upon offer acceptance.