Job Description:

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing. Position Summary We are seeking a highly skilled and experienced Senior Quality Assurance (QA) Scientist to join our client's team. In this senior-level role, you will be a key driver of product quality, regulatory compliance, and continuous improvement initiatives across the organization. You will apply deep technical expertise to design and execute quality systems and serve as a cross-functional quality partner to R D, manufacturing, and regulatory affairs. Key Responsibilities Quality Systems & Compliance Design, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with applicable regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, or industry equivalent). Lead and manage internal and external audits, including pre-audit preparation, execution, and CAPA follow-up. Maintain current knowledge of applicable regulations (FDA, EU MDR, ICH, GxP) and ensure organizational compliance through proactive gap assessments. Develop, review, and approve SOPs, work instructions, and quality documentation to ensure clarity and regulatory adherence. Oversee change control processes, ensuring all changes are properly documented, evaluated for risk, and validated prior to implementation. Testing, Validation & Analytical Methods Design and execute validation protocols (IQ/OQ/PQ) for equipment, processes, software, and analytical methods. Develop and validate test methods in compliance with relevant pharmacopeial or industry standards; perform method transfers. Lead root cause investigation and failure analysis using structured problem-solving methodologies (8D, Ishikawa, 5-Why, FMEA). Review and approve batch records, test results, and deviations; ensure disposition decisions are science-based and defensible. Oversee stability programs, environmental monitoring, and in-process controls to ensure product integrity. Cross-Functional Leadership & Continuous Improvement Serve as the quality representative on cross-functional project teams, providing QA guidance from design through launch. Partner with R D, Regulatory Affairs, Manufacturing, and Supply Chain to drive quality-by-design principles. Lead Corrective and Preventive Action (CAPA) system; track and report trends in quality metrics to senior leadership. Mentor and coach junior QA staff, fostering a culture of quality, accountability, and continuous improvement. Identify and implement process improvement initiatives using Lean, Six Sigma, or other quality improvement frameworks. Qualifications Required Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; Master's or Ph.D. preferred. Minimum 7 years of progressive, hands-on quality assurance experience in a regulated industry (pharmaceutical, biotech, medical device, or equivalent). In-depth knowledge of quality regulations and standards:

FDA 21 CFR

Parts 210/211/820, ISO 13485, ICH

Q7/Q8/Q9/Q10, EU GMP

Annex, or equivalent. Proven experience designing and executing validation protocols (process, method, equipment, CSV/computer systems). Demonstrated experience leading or supporting regulatory inspections (FDA, EMA, ISO/Notified Body) with successful outcomes. Strong root cause analysis skills with hands-on use of tools such as FMEA, Fishbone, 5-Why, and 8D. Experience authoring, reviewing, and approving complex quality documentation including SOPs, protocols, and technical reports. Proficiency with quality management software (e.g., MasterControl, Veeva, TrackWise, or similar platforms). Preferred ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification. Six Sigma Green Belt or Black Belt certification. Experience with electronic batch record systems and data integrity programs (21 CFR Part 11 / Annex 11). Prior experience with combination products or Class II/III medical devices. Familiarity with supplier quality management and qualification programs. Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.

California residents:

Qualified applications 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. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/ Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

Benefits Information:

Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings. We look forward to working with you! Beacon Hill. 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Senior Quality Assurance Scientist