Compliance Associate II

About the Role

We are seeking a highly motivated and detail-oriented Compliance Associate II to support and strengthen our Quality Management System (QMS) and site compliance programs. This role plays a critical part in maintaining regulatory compliance, driving quality system effectiveness, supporting inspection readiness, and ensuring adherence to cGMP requirements. As a key member of the Quality organization, you will independently manage quality system processes, including Deviation Management, Change Control, and Cleaning Validation, while partnering with cross-functional teams to promote continuous improvement and inspection readiness across the site.

Responsibilities

• Quality Systems Management
  • Independently manage and perform preliminary assessments for deviations within TrackWise.
  • Independently review and manage change controls and facilitate Change Review Board (CRB) meetings to ensure effective evaluation and implementation of proposed changes.
  • Monitor deviation and change control lifecycles to ensure timely investigations, extensions, approvals, and closures.
  • Collaborate with cross-functional teams to drive quality events to completion and maintain compliance with established procedures.
  • Ensure compliance with Data Integrity (ALCOA+) principles across investigations, validation documentation, and GMP records.
• Quality Metrics & Continuous Improvement
  • Collect, analyze, trend, and report quality metrics related to deviations and change controls on a monthly, quarterly, and annual basis.
  • Identify recurring compliance risks, emerging trends, and improvement opportunities.
  • Escalate significant findings and recommend corrective and preventive actions.
  • Prepare quality summaries and presentations for Quality Management Reviews (QMRs) and leadership meetings.
• Cleaning Validation Program Management
  • Maintain and oversee the site's Cleaning Validation Program.
  • Develop and maintain the Cleaning Validation Master Plan (CVMP).
  • Support the lifecycle management of cleaning validation activities, including:
    • Initial validation
    • Periodic review
    • Revalidation strategies
    • Continued verification activities
  • Design, review, and approve cleaning validation protocols and reports.
  • Conduct risk assessments for cleaning processes and validation activities.
  • Evaluate:
    • Worst-case product selection
    • Sampling strategies (swab and rinse)
    • Analytical methods
    • Acceptance criteria
  • Ensure appropriate establishment, justification, and documentation of MACO (Maximum Allowable Carryover) limits.
  • Assess validation impacts resulting from deviations, investigations, and process changes.
• Audit & Inspection Readiness
  • Support the site's FDA and regulatory inspection readiness programs.
  • Participate in mock inspections, compliance assessments, and gap analyses.
  • Provide support during:
    • FDA inspections
    • Customer audits
    • Internal audits
    • Corporate audits
  • Assist with audit coordination, documentation requests, and back-room support activities.
  • Support investigation reviews and compliance-related projects as needed.

Work Environment

This position operates in a combination of office, laboratory, and manufacturing environments. The role requires frequent interaction with Quality, Manufacturing, Validation, and Regulatory teams to support site compliance initiatives.

• The work environment may include:
  • Manufacturing and production areas
  • Laboratories and support areas
  • Moderate noise levels
  • Periodic use of personal protective equipment (PPE)

Physical Requirements

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, and reach as needed.
• Ability to lift and carry up to 20 pounds.
• Ability to navigate office, laboratory, warehouse, and manufacturing environments.
• Must be able to wear required PPE, including respirators, safety glasses, and safety shoes.

Requirements

• Education
  • Bachelor's degree required.
• Experience
  • Minimum 4 years of experience in a Quality Assurance role within the pharmaceutical industry.
  • Experience managing or supporting deviations, change controls, investigations, and compliance programs.
  • Experience working within a matrixed, global, or multicultural organization preferred.
• Technical Knowledge & Skills
  • Demonstrated experience with Quality Management Systems (QMS) and quality event management.
  • Strong knowledge of cGMP regulations, quality systems, and pharmaceutical compliance requirements.
  • Experience driving investigations, deviations, and change controls to closure.
  • Working knowledge of:
    • TrackWise or similar QMS platforms
    • Learning Management Systems (LMS)
    • Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
    • Data analysis and trending tools
  • Strong understanding of cleaning validation principles and regulatory expectations.
  • Knowledge of ALCOA+ data integrity principles.
• Professional Skills
  • Strong project management and organizational skills.
  • Excellent written, verbal, and presentation skills.
  • Ability to manage multiple priorities simultaneously while maintaining attention to detail.
  • Strong analytical, problem-solving, and decision-making capabilities.
  • Ability to work independently and collaboratively across cross-functional teams.
  • Self-motivated with a hands-on, proactive approach and a continuous improvement mindset.
  • English language proficiency at CEFR Intermediate B1+ level.

Travel

Up to 5%

Benefits

• This position is part of the Annual Performance Bonus Plan and may be eligible for the Long Term Incentive Plan.
• Employees are eligible to participate in Company employee benefit programs which include:
  • Medical, dental, and vision coverage
  • Life insurance
  • Disability insurance
  • 401(k) savings plan
  • Flexible spending accounts
  • Employee assistance program
• Employees also receive various paid time off benefits, including vacation time and sick time.

Pay

The presently-anticipated base compensation pay range for this position is $74,000 to $82,500. Actual base compensation may vary based on factors including but not limited to geographical location and experience.