Job Summary:

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.\nAs 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:

\nQuality Systems Management Independently manage and perform preliminary assessments for deviations within TrackWise.\nIndependently review and manage change controls and facilitate Change Review Board (CRB) meetings to ensure effective evaluation and implementation of proposed changes.\nMonitor deviation and change control lifecycles to ensure timely investigations, extensions, approvals, and closures.\nCollaborate with cross-functional teams to drive quality events to completion and maintain compliance with established procedures.\nEnsure 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.\nIdentify recurring compliance risks, emerging trends, and improvement opportunities.\nEscalate significant findings and recommend corrective and preventive actions.\nPrepare 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.\nDevelop and maintain the Cleaning Validation Master Plan (CVMP).\nSupport the lifecycle management of cleaning validation activities, including: Initial validation\nPeriodic review\nRevalidation strategies\nContinued verification activities Design, review, and approve cleaning validation protocols and reports.\nConduct risk assessments for cleaning processes and validation activities.\n

Evaluate:

Worst-case product selection\nSampling strategies (swab and rinse)\nAnalytical methods\nAcceptance criteria Ensure appropriate establishment, justification, and documentation of MACO (Maximum Allowable Carryover) limits.\nAssess validation impacts resulting from deviations, investigations, and process changes. Audit & Inspection Readiness Support the site's FDA and regulatory inspection readiness programs.\nParticipate in mock inspections, compliance assessments, and gap analyses.\nProvide support during: FDA inspections\nCustomer audits\nInternal audits\nCorporate audits Assist with audit coordination, documentation requests, and back-room support activities.\nSupport investigation reviews and compliance-related projects as needed.

Work Environment:

\nThis 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.\nThe work environment may include: Manufacturing and production areas\nLaboratories and support areas\nModerate noise levels\nPeriodic use of personal protective equipment (PPE)

Physical Requirements:

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

Travel:

Up to 5%

What You Bring:

\nEducation Bachelor's degree required. Technical Knowledge & Skills Demonstrated experience with Quality Management Systems (QMS) and quality event management.\nStrong knowledge of cGMP regulations, quality systems, and pharmaceutical compliance requirements.\nExperience driving investigations, deviations, and change controls to closure.\nWorking knowledge of: TrackWise or similar QMS platforms\nLearning Management Systems (LMS)\nMicrosoft Office Suite (Excel, Word, PowerPoint, Outlook)\nData analysis and trending tools Strong understanding of cleaning validation principles and regulatory expectations.\nKnowledge of ALCOA+ data integrity principles. Professional Skills Strong project management and organizational skills.\nExcellent written, verbal, and presentation skills.\nAbility to manage multiple priorities simultaneously while maintaining attention to detail.\nStrong analytical, problem-solving, and decision-making capabilities.\nAbility to work independently and collaboratively across cross-functional teams.\nSelf-motivated with a hands-on, proactive approach and a continuous improvement mindset.\nEnglish language proficiency at CEFR Intermediate B1+ level.

Experience:

Minimum 4 years of experience in a Quality Assurance role within the pharmaceutical industry.\nExperience managing or supporting deviations, change controls, investigations, and compliance programs.\nExperience 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.\nGain exposure to critical quality systems, cleaning validation programs, and regulatory interactions.\nPartner with cross-functional teams to drive compliance excellence and continuous improvement.\nWork in a collaborative environment dedicated to quality, patient safety, and operational excellence.\nBuild 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.\nThe 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.\nThe 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).\nWe 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.\nNotice to

Agency and Search Firm Representatives:

\nSun 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. 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