Associate Director Post Marketing Quality

Arcutis Biotherapeutics

2d

About The Position

The Associate Director of Post-Marketing Quality Assurance is responsible for leading quality oversight activities that ensure continued compliance of commercial pharmaceutical products throughout their lifecycle. This role provides strategic and operational oversight of third party logistics centers, distribution partners, and pharmacovigilance interfaces to ensure regulatory compliance, product quality, and supply continuity. This person will also represent quality on the commercial launch team to ensure implementation of these elements are incorporated into product launch timelines.

The Associate Director will drive post-approval quality strategy, manage quality systems related to commercial products, support inspections, and partner cross-functionally with Regulatory Affairs, Supply Chain, Safety, and Technical Operations.

Requirements

• Bachelor’s degree preferred or at least 5 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements.
• Comfortable using quality tools such as lean, six sigma, risk management and other risk-based tools to continually improve operations.
• Ability to successfully interact with regulatory health authorities.
• Ability to lead and influence cross functional employees to ensure compliance.
• Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Proficient in MS Word, Excel, Power Point.
• Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• Strong knowledge of GMP, SOPs and quality systems as they relate to document management.

Nice To Haves

• ASQ Auditor certification a plus.
• Veeva QMS a plus.

Responsibilities

• Manage product complaints, field alerts, and product recalls. Assure close collaboration with medical affairs and product safety teams.
• Lead for potential defective product, serious deviation, or recall/Field Corrective Actions and reporting appropriate Regulatory Agency.
• Identify quality and performance objectives; analyze metrics and report trends to management.
• Participate in supplier qualification activates (e.g., conduct supplier audits, develop and implement quality agreements, etc.).
• Oversight of suppliers involved in the packaging, labeling and distribution of Arcutis commercial products.
• Ensure timely investigation, root cause analysis, and CAPA implementation.
• Release of Finished Products for distribution in US.
• Label and artwork review and approval for US.
• Review of batch-related documentation to ensure GMP compliance for release of Finished Product.
• Oversight of deviation investigations for packaging and shipping events.
• Provide QA oversight and approval of Change Control records impacting product distribution, implementation, and management of jurisdictional control.
• Ensure distribution procedures align with expectations and requirements for US FDA, and other country/state boards of health as required.
• Author and/or revise controlled documents related to various Quality Systems (e.g. SOPs, Controlled Forms, Work Instructions, etc.).
• Other duties that may be assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees