New

Sr. Compliance Associate

YOH Services LLC
United States, California, San Diego
3131 Camino Del Rio North (Show on map)
Apr 05, 2025
Sr. Compliance Associate Category: Life Science Employment Type: Direct Hire Reference: BH-383636 A Biopharmaceutical organization in the San Diego area is seeking a highly experienced Sr. Compliance Associate to join its Quality team. This individual will play a key role in ensuring compliance with internal and external quality standards, particularly in preparation for and during audits and regulatory inspections. Title: Sr. Compliance Associate Location: Greater San Diego, CA Area Schedule: Monday-Friday Key Responsibilities: Support Quality Compliance and Inspection Readiness initiatives across the organization Author, review, and approve controlled documents (SOPs, protocols, reports) for compliance with applicable regulations and standards Support internal and external audits, as well as regulatory inspections, including logistics, documentation, and real-time support Evaluate and improve existing Quality Systems and processes; assist in the implementation of enhancements Coordinate and track site quality metrics and risk assessments Lead backroom activities and interface with auditors and inspectors during audits/inspections Support deviation investigations, CAPAs, and other quality-related records Maintain customer audit and internal audit programs Provide GMP training to internal stakeholders Assist with electronic Quality Management System (eQMS) operations and data entry Qualifications: Bachelor's degree in Life Sciences or a related field 5+ years of relevant experience in a GMP-regulated biopharmaceutical or biotech environment Strong knowledge of global GMP regulations (FDA, EMA, etc.), cGMPs, 21 CFR, USP, and other relevant guidance Proven experience supporting regulatory inspections and internal/external audits from the Quality function Strong attention to detail with excellent documentation and communication skills Proficiency with Microsoft Office and electronic quality systems Ability to work independently in a fast-paced, regulated environment Estimated Min Rate: $110000.00 Estimated Max Rate: $120000.00 #IND-SPG Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.