Manager Quality Systems - EDMS, Patient Safety and Change Control (On Site)

Purpose and Scope

This position is responsible for providing oversight and continuously improving the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, 21 CFR Parts 210/211, and EU MDR. This role includes ownership of key processes such as document control, customer complaints, and change control, ensuring that these areas meet regulatory requirements and support the organization's commitment to quality.

Essential Duties & Responsibilities

General:

• Participate on cross-functional teams, representing Quality Systems, to drive shared understanding of quality requirements and continuous improvement.
• Drive QMS effectiveness using data and metrics across CAPA, document/records management, training, change control, nonconformance/deviations, and management review.
• Maintain current and acquire new knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches.
• Integrate Tolmar's core values into team goals and decision-making.
• Develop and implement processes, procedures, forms, work instructions, and tools to support compliance systems.
• Support the Director Quality Systems & Compliance by coordinating projects, solving problems, and designing process improvement solutions.
• Participate in regulatory, third-party, and customer audits/inspections and support timely corrective action responses.
• Represent the Tolmar Quality Systems & Compliance management team and reflect Tolmar Values as a role model to employees, suppliers, and customers.
• Perform other related duties as assigned.

Electronic Document Management System (EDMS) and Document Control Oversight:

• Lead the document control team; set standards, coach staff, and ensure documentation compliance.
  
  
  
  • Own and optimize EDMS administration (e.g., Veeva) for document storage, routing, and approvals.
  • Maintain document control procedures aligned to regulatory requirements (US and rest of world).
  • Lifecycle Management: Manage document creation, review/approval, revision control, distribution, archiving, and destruction (e.g., SOPs, batch records, quality records).
    
    
    
    • Manage batch records/master batch records and lot number issuance.
    
    
    
    
  • Data Integrity: Maintain current, accurate, accessible quality records in accordance with ALCOA+.
  • Regulatory Compliance & Quality:
    
    
    
    • Ensure documents meet cGMP and ICH requirements.
    • Provide documentation support and responses for internal audits, partner audits, and health authority inspections.
    
    
    
    
  
  
  
  

Customer Complaint Handling:

• Complaint Program Ownership: Manage the end-to-end complaint handling process, including intake, investigation, regulatory reporting, and closure.
• Trending & Escalation: Analyze complaint data to identify trends, escalating serious issues to senior management and initiating Corrective and Preventive Actions (CAPA) when necessary.

• Customer Communication: Liaise with customer technical support to facilitate investigations and responses.

Change Control and Management:

• Establish change management metrics and reporting to drive transparency, accountability, and on-time closure across the change lifecycle.
• Change Control Administration:
  
  
  
  • Oversee review, approval, and implementation of changes impacting products, processes, or systems.
  
  
  
  
• System Oversight:
  
  
  
  • Manage the change control process, ensuring changes are tracked, documented, and approved within the quality management system.
  • Track change control KPIs and report results to senior leadership.
  • Ensure change control activities comply with regulations and internal procedures.
  • Audit the change control process to confirm compliance and identify improvements.
  
  
  
  
• Impact Assessment & Risk Management:
  
  
  
  • Perform risk assessments (ISO 14971) for proposed changes to protect compliance and product quality.
  • Lead cross-functional risk assessments of changes (e.g., FMEA) to evaluate impact on product quality and safety.
  
  
  
  
• Change Control Board (CCB): Facilitate CCB review and disposition of change requests (approve/reject/modify).
• Implementation & Closure: Ensure required actions (e.g., SOP updates, validation) are completed and effective before closure.
• Documentation & Support: Maintain change documentation (justification, impact assessment, and validation evidence).

Quality System Compliance & Improvement:

• Collect, analyze, and present EDMS, complaint, and change control KPIs for management review.
• Partner with management to set and deliver Quality Objectives.
• Drive continuous improvement to strengthen QMS (Quality Management System) performance and compliance.
• Use audits, data analysis, and risk-based controls to identify gaps, reduce risk, and improve metrics.
• Coordinate cross-functional actions to resolve critical quality issues and verify effectiveness.
• Lead department and cross-functional projects and operational tasks, partnering with Tolmar and affiliates as needed.

Department Management:

• Implement strategies to achieve company objectives and clarify expectations for staff.
• Manage department headcount and budget to support effective resource planning.
• Recruit, select, onboard, train, and assign work to ensure appropriate coverage and priorities.
• Use Tolmar's performance management program to set expectations, provide timely feedback, hold staff accountable, and conduct goal setting and performance reviews.
• Build quality knowledge across the team by developing and deploying skill assessments and training plans.
• Ensure staff comply with applicable SOPs, quality regulations/standards (e.g., ISO, FDA), and required EHS/HR policies.
• Maintain regular communication with the team and department leadership via one-on-ones, team meetings, and other channels.
• Manage and coach lower-level managers to build high-performing teams and deliver department operations aligned to Tolmar's core values and leadership model.
• Monitor personnel and operations to identify issues early and partner with senior leadership and Human Resources as needed.
• Identify operational needs; delegate or author procedures, work instructions, and templates supporting Quality System activities.
• Develop metrics and data collection methods; analyze results, recommend actions, and prepare management review reports and minutes.
• Develop the department budget and monitor expenditures.

Communication and Collaboration:

• Serve as a key point of contact for quality issues and assigned quality system elements.
• Partner with cross-functional leaders to meet business, quality, and compliance objectives.
• Help departments prepare and analyze data and apply root cause analysis tools, then communicate findings to senior management.
• Escalate issues and engage stakeholders as needed to ensure timely completion of investigations, impact analyses, and CAPA records.
• Ensure CAPA investigations and associated actions are adequate and effective to maintain compliance and prevent recurrence.

Knowledge, Skills & Abilities

• Comprehensive knowledge of current Good Manufacturing Practices (cGMP) for finished pharmaceuticals and/or medical devices.
• Ability to integrate quality principles, document/record management, Lean, and risk management into daily operations to balance compliance and business goals.
• Ability to use critical thinking and systems decision-making to analyze complex situations, evaluate options, and implement solutions.
• Ability to build trust and rapport to lead teams and collaborate across organizational boundaries.
• Ability to operate effectively in ambiguous, fast-changing environments; remain flexible and resilient.
• Ability to influence and negotiate with stakeholders to achieve outcomes and maintain productive relationships.
• Ability to prevent and resolve conflicts while fostering a constructive, inclusive work environment.
• Ability to identify, assess, and mitigate risks using systematic problem-solving and root cause analysis to prioritize and resolve quality issues.
• Strong communication skills in writing and verbally; ability to develop and deliver effective presentations and training.
• Proficient with Microsoft Office and standard documentation tools (e.g., Visio, Adobe Acrobat) for analysis, reporting, and documentation.
• Ability to apply data analysis to support decisions and drive continuous improvement.
• Strong understanding of finance and budgeting processes to support planning and resource allocation.

Core Values

The Manager Quality Systems - EDMS, Patient Safety and Change Control 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 Engineering, Life Sciences, or related field required.
• Seven (7) or more years of Quality Assurance experience in a GMP/regulated environment (Pharma or Medical Device).
• Five (5) or more years of supervisory experience required; experience supervising remote-hybrid direct reports preferred, including experience managing or leading junior level management and teams in a regulated manufacturing environment.
• Three (3) or more years of successful auditing and inspection experience, including managing the preparation for and hosting of regulatory inspections, including successfully resolving issued nonconformance/violations (e.g., 483s).
• Demonstrated proficiency in Electronic Quality Management Systems (eQMS) such as Veeva.
• Deep understanding of FDA 21 CFR Part 820, 21 CFR Parts 210/211, and ISO 13485.

Working Conditions

• Conditions are normal for an office environment.
• This is an on-site position in Fort Collins / Windsor Colorado.
• Travel may be required on occasion.

Compensation and Benefits

• Annual pay range $125,000 - $140,000 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.