Specialist, Compliance

About the role

As the Specialist, Compliance you will lead and author GMP investigations related to deviations, nonconformances, audit findings, and other quality events in a pharmaceutical manufacturing environment. You will partner cross-functionally with Manufacturing, Quality Control, Engineering, Validation, Information Systems, Supply Chain, and the Quality team to ensure thorough root cause analysis, effective CAPAs, and sustained regulatory compliance. You will be responsible for the timely and accurate completion of compliance documentation, supports an inspection-ready state, and contributes to a strong quality culture through risk-based, right-first-time investigation execution.

Responsibilities

• Investigation Leadership & Documentation
  • Lead and author GMP deviations, nonconformances, and quality investigations.
  • Drive root cause analysis using structured tools (e.g., 5 Whys, Fishbone, Fault Tree, human performance concepts).
  • Ensure investigations are thorough, scientifically sound, and compliant with regulatory expectations.
  • Facilitate cross-functional investigation meetings and follow up on action items.
  • Ensure investigations are completed right-first-time and within required timelines.
• CAPA Management
  • Develop, document, implement (as assigned), and track effectiveness of Corrective and Preventive Actions (CAPAs).
  • Escalate risks when CAPAs are inadequate, overdue, or ineffective.
  • Ensure assigned action items are completed within the required timelines.
• Change Management
  • Initiate Change Controls and complete assigned action tasks.
  • Ensure assigned tasks are completed within the required timelines.
• Regulatory & Inspection Readiness
  • Support inspections and internal audits.
  • Participate in inspection back-room support and follow-up activities as needed.
• Risk Assessment & Decision Support
  • Perform and document risk assessments (e.g., product impact, patient safety, data integrity).
  • Identify investigation trends and recurring issues; escalate systemic risks.
• Quality Systems & Continuous Improvement
  • Support continuous improvement of investigation and deviation processes.
  • Identify opportunities to improve compliance, documentation quality, and investigation cycle time.
  • Contribute to metrics, dashboards, and trending reports related to deviations and CAPAs.
• Collaboration & Training
  • Serve as a compliance partner to Manufacturing and support functions.
  • Support training initiatives related to deviations, investigations, and GMP expectations.

Requirements

• Bachelor’s degree in a scientific or technical discipline or equivalent experience.
• In lieu of a degree, 6+ years of experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment, including leadership of deviations, investigations, and CAPAs.
• 3+ years of experience in pharmaceutical manufacturing, quality, or another regulated environment, with hands-on involvement in GMP deviations or investigations.
• Working knowledge of cGMP regulations, FDA guidance related to investigations and CAPA, and data integrity principles (ALCOA+).
• Experience writing, reviewing, and executing SOPs; proficiency with electronic quality management systems (eQMS) preferred.
• Strong technical writing, documentation, and organizational skills; ability to apply risk-based critical thinking.
• Proven ability to facilitate cross-functional discussions, drive accountability, and maintain independence, integrity, and professionalism.
• Experience with electronic compliance systems (oneERP, QA-Track, Veeva).
• Proficient in Microsoft Office; familiarity with Lean Six Sigma concepts preferred.
• Onsite presence required; may require extended hours, off-shift, or weekend support during investigations, audits, or inspections.
• Comfortable working in a fast-paced, high-compliance manufacturing environment.

Physical Requirements

• Ability to work in a manufacturing and office environment, including laboratories and production areas.
• Ability to sit, stand, and walk for extended periods throughout the workday.
• Ability to use a computer and standard office equipment for prolonged periods.
• Ability to read, write, and communicate effectively to review and prepare technical and compliance documentation.

Pay

The base salary range for this role is $76,831 to $142,685. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus—payouts are based on individual and company performance.

Benefits

• Comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees.
• 401k plan and company match.
• Short and long-term disability coverage.
• Basic life insurance.
• Wellness benefits.
• Reimbursement for certain tuition expenses.
• Sick time of 1 hour per 30 hours worked.
• Vacation time for full-time employees to accrue up to 120 hours in the first four years of employment, and 160 hours in the fifth year of employment.
• 15 paid holidays per year.
• Paid parental leave subject to a minimum period of employment at Ferring.