Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) · 1 month ago
Senior Manager Quality Control
United States
Full-time
Remote
Senior Level
$150K/yr - $160K/yr
5+ years expArcutis Biotherapeutics, Inc. is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. The Senior Manager Quality Control will be responsible for managing the Quality Control program, ensuring compliance with regulatory guidelines, and overseeing the testing and release process for commercial products.
BiopharmaBiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics
Responsibilities
Manage 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
Provide primary support and oversight of analytical development for new product development teams under design controls, focusing on analytical and CMC deliverables including providing strategic direction, establishing regulatory and manufacturing specifications, reviewing and approving technical protocols and reports (e.g. Pharmaceutical Development Report, analytical method development and validations, leachable/extractable studies, stability studies)
Providing guidance on test method development, validation, verification and transfer that are scientifically sound and meet regulatory standards. Review and approve analytical method development, validation and transfer protocols and reports
Provide strategic input, technical soundness and review and approval of OOS investigations and CAPAs for product, process or materials
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
Develop metrics to evaluate third-party laboratories working in partnership with Quality Assurance, assist in negotiating effective supply/technical agreements
Participate in cross functional project teams for product development as analytical development functional area representative
Provide strategic direction to cross functional teams on regulatory submissions (e.g. IND/NDA, annual reports, etc.), including authoring, review and approval of CMC sections
Develop, implement and maintain analytical related Quality System procedures and processes
Author relevant sections of regulatory documents, including Study Protocols, IND filings, IMPD, and DMFs
Track proposals and invoices to insure alignment with approved budget
Manage consultants, vendors, and CMOs 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
Manages and oversees the activities of external contract entities, including consultants and contractors
Qualification
Required
Typically requires a BA, BS or MS in Chemistry, Biology, Biochemistry, Pharmaceutical Science or a degree in a related scientific discipline and 5+ years of related experience, or the equivalent combination of education and experience
Demonstrate ability to lead teams, manage projects, and drive continuous improvement initiatives
A successful track record in selecting and managing CROs/CMOs, including site qualification, technical transfer, clinical supply logistics, and oversight of activities
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
Ability to multi-task/ prioritize and time manage of daily activities with little oversight
Demonstrates a high level of accuracy and effective oral and written communication skills
Flexibility within a rapidly changing environment
Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
Proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)
The ability to work independently and within a team structure and on multiple projects, with flexibility to adapt to changing priorities is required
This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills
Travel may be required for up to 10% of time worked
Company
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT)
Arcutis (Nasdaq: ARQT) was founded in 2016 to address significant unmet needs in medical dermatology.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$833.5MKey Investors
SLR Capital PartnersHBM Healthcare InvestmentsOrbiMed
2024-02-28Post Ipo Equity· $150M
2023-10-19Post Ipo Equity· $100M
2022-08-02Post Ipo Equity
Leadership Team
Frank Watanabe
President and Chief Executive Officer
Latha Vairavan
Chief Financial Officer
Recent News
2026-01-12
The Motley Fool
2025-12-14
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