Partner Therapeutics · 15 hours ago
External Quality Assurance IV (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$130K/yr - $145K/yr
8+ years expPartner Therapeutics is a company focused on biologic products and their quality assurance. The QA Specialist IV External Quality Assurance role is responsible for ensuring the overall quality of biologic products and overseeing CMO operations to ensure compliance with regulatory standards and good manufacturing practices.
BiotechnologyHealth CareMedicalMedical DeviceTherapeutics
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
Qualification
Required
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
Preferred
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
Life insurance coverage
Casual workplace program
Hybrid or Remote workplace program
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
Holiday paid time off program
Paid shutdown between the Christmas and New Year’s holidays
Company
Partner Therapeutics
PTx is a biopharmaceutical company committed to the development and commercialization of therapies that improve the treatment of cancer.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$60M2018-02-01Series A· $60M
Leadership Team
Martha Katz
Associate Director, New Product Planning and Operations Management at Partner Therapeutics
Sanjeev Ahuja, MD, MBA, FACP
Chief Development Officer: Neurology, Critical Care and Health Security
Recent News
MarketScreener
2025-10-23
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