Sr Mgr Quality Control at Arcutis Biotherapeutics Inc in Westlake Village, California

Job Description:

The Senior Manager, Quality Control is responsible for working with internal and external team members to meet Company timelines and objectives for Arcutis Drug Products. Oversees all quality control activities related to the testing, reviewing, and releasing topical pharmaceutical products and supporting the commercial release of products. This role ensures compliance with Good Manufacturing Practices (GMP), FDA, ICH, USP and other regulatory standards, while working cross-functionally with Quality Assurance (QA), Manufacturing, Regulatory Affairs, and Supply Chain to ensure timely product release.Roles & ResponsibilitiesManage the QC testing and release process for commercial topical products, ensuring timely lot disposition.Review and approve batch records, Certificates of Analysis (CoA), analytical test results, and stability data to ensure compliance with regulatory and product specifications.Coordinate with QA, Manufacturing, and Regulatory Affairs to resolve deviations, Out-of-Specification (OOS) results, and non-conformances related to lot release.Ensure data integrity and adherence to ALCOA+ principles for all QC-related documentation.Oversee physical, chemical, and microbiological testing of topical drug products, including pH, viscosity, particle size analysis, IVRT, and microbiological limits.Ensure compliance with USP monographs, ICH guidelines, and FDA regulations for topical formulations.Support FDA, EMA, and internal/external audits, ensuring all documentation and records are audit-ready.Identify opportunities to streamline QC testing, sample management, and release timelines for commercial topical products.Identify and manage contract analytical laboratory site(s) required to guide and support third-party manufacturing relationships.Identify, select, qualify, and oversee contract laboratories for analytical testing services, including contract negotiations, on-site audits, and supplier development activities.Track proposals and invoices to ensure alignment with the approved budget.Manage vendors, CMOs, and CTLs to meet agreed-upon program timelines/budgets.Act as the primary company liaison for contract analytical laboratories conducting Quality Control testing; ensure timely testing and quality product. Education & Licenses and ExperienceTypically requires a Bachelor’s degree with 7+ years of experience or a Master’s degree with 5+ years of experience in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field and experience in Quality Control within the pharmaceutical, cosmetic, or personal care industry with a focus on topical formulations. Competencies & SkillsMust have experience with topical formulations (creams, ointments, gels, and foams).A successful track record in selecting and managing CROs/CMOs, including site qualification, technical transfer, clinical supply logistics, and oversight of activities. In-depth knowledge and full understanding of GMP requirements and regulatory requirements for topical drug candidates.Proficiency in LIMS, TrackWise, SAP, and other quality management systems is preferred.Ability to multi-task/ prioritize and time manage daily activities with little oversightDemonstrated ability to lead teams, manage projects, and drive continuous improvement initiatives.Demonstrate ability to lead teams, manage projects, and drive continuous improvement initiatives. Strong knowledge of GMP, FDA, ICH, and USP regulations for topical drug products.Experience with analytical techniques such as HPLC, GC, pH, IVRT and particle size analysis for topical formulations. Familiarity with microbiological testing (e.g., microbial. Limits, sterility, endotoxin testing) for non-sterile topical products. Demonstrates a high level of accuracy and effective oral and written communication skills.Flexibility within a rapidly changing environmentAbility to travel up to 30%
Why Join Us? 
 
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exciting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!
  
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.California Employee/Applicant Privacy Notice

Equal Opportunity Employer, including disability/protected veterans


Equal employment opportunity, including veterans and individuals with disabilities.
PI264540172

Salary:

$145,000.00

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