External Quality Assurance IV (Remote)

About the position The QA Specialist IV External Quality Assurance (ExQA) role is responsible for the overall quality of biologic products and directly involved with CMO oversight of drug substance, sterile drug product and finished product manufacturing.). The scope of responsibility can include quality and business process support for new product introduction, product monitoring and post-market quality systems. The individual is responsible for assuring compliance with current good manufacturing practices and regulatory compliance requirements and ensuring products, materials and services are procured, released and monitored via established systems.

Responsibilities

• Primary Quality point of contact for CMOs.
• Ensures timely Quality review/approval of CMO deviations, change controls and batch release requirements and integrates these records into Partner Therapeutics’ (“PTx”) cGMP systems.
• Ensures timely Quality review/approval of documents required to support technology transfer.
• Responsible for the development, continuous improvement, coordination and ensuring compliance for all Quality aspects of the lifecycle stages of CMO Management.
• Acts as a liaison between Quality Assurance, Regulatory, and our CMO partners in providing compliance oversight for regulatory submissions supporting technology transfer/existing CMO production, ensuring timely Quality review/approval of required regulatory documents.
• Oversees change control implementations at CMOs, including timely Quality review/approval of documents and coordinating impact assessments from Subject Matter Experts.
• Supports PTx Regulatory Intelligence role in the development and implementation of updates affecting CMO operations.
• Supports PTx inspection readiness for CMO activities in alignment with good manufacturing practices, regulatory compliance requirements and current industry standards, including inspection walkthrough and preparedness activities, response management, and tracking.
• Supports the other departmental responsibilities, including post market surveillance, product quality complaint investigations, and product labeling.
• Supports/coordinates cGMP investigations for drug and finished product, CMO deviations, and integration into appropriate PTx Northpointe Quality Systems.
• Contributes to Annual Product Review process and coordinates CMO deliverables to ensure timeliness of APR.
• Resolves issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.

Requirements

• Ability to demonstrate thorough understanding and knowledge of drug product manufacturing cGMP requirements, including 21 CFR 210/211, FDA Guidance for Industry, ICH Guidelines, and Industry trends.
• Proven ability implementing external agency regulations.
• Proven ability to read, understand, and interpret complex regulations, guidance documents, specifications and compendial requirements required.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Proven ability to solve complex problems with high attention to detail, precision, and ability to find errors or inconsistencies.
• Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.
• Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected change and challenges.
• Strong written and oral English communication skills are required for this highly collaborative role.
• Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required.
• Skilled at leading effective meetings.
• Solid software skills essential including Word, Excel, PowerPoint, and Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.
• High School Diploma or GED.
• 8+ years of progressively responsible experience and 2+ years of directly applicable experience in the External Manufacturing biotech/pharmaceutical industry with emphasis in Quality Operations set in a cGMP environment.
• Recent experience with drug and finished product fill finish operations.

Nice-to-haves

• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management experience or formal training.
• Product Labeling and Product Complaint experience
• BA, BS or equivalent degree strongly preferred.
• Lyophilization experience strongly preferred.

Benefits

• medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage
• casual, and Hybrid or Remote workplace program for many roles
• pre-IPO options
• annual cash bonuses
• 401k matching
• free parking or Seattle-area ORCA pass
• tuition assistance
• rewards for achievement and contribution
• gym subsidy
• wellness participation programs
• generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays

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