Senior Manager Quality Control

Role Summary

The Senior Manager Quality Control, under the direction of the Director, will be responsible for planning, implementing and managing initiatives for Arcutis and will proactively oversee the Quality Control program for compliance with ICH/FDA/EMA Guidelines. They will work closely with internal and external team members to meet Company timelines and objectives for Arcutis drug products, as well as preparation of CMC sections for regulatory submissions and responsible for participating in and supporting novel drug development projects.

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+ principlesfor 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.

Qualifications

• 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.

Skills

• 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.

Education

• BA, BS or MS in Chemistry, Biology, Biochemistry, Pharmaceutical Science or a related scientific discipline

Additional Requirements

• Travel may be required for up to 10% of time worked.