Title:  Compliance Associate II

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.

What You'll Do:

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.

Travel: Up to 5%

What You Bring:

Education

• Bachelor's degree required.

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.

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.

Why Join Us?

• Play a key role in maintaining and advancing site compliance and inspection readiness.
• Gain exposure to critical quality systems, cleaning validation programs, and regulatory interactions.
• Partner with cross-functional teams to drive compliance excellence and continuous improvement.
• Work in a collaborative environment dedicated to quality, patient safety, and operational excellence.
• Build your career within a growing pharmaceutical organization focused on innovation and compliance.

If you're a quality professional who thrives on problem-solving, compliance excellence, and continuous improvement, we'd love to hear from you. Join us and help ensure the quality and integrity of products that make a difference in patients' lives.

The presently-anticipated base compensation pay range for this position is $74,000 to $82,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, 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; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.