Job Description

Manager, Quality Assurance
Location: West Coast US+Canada (Hyrbid)
The Manager, Quality Assurance, is responsible for ensuring investigational medicinal products (IMPs) meet current Good Manufacturing Practices (cGMP). This role serves as a quality partner to internal teams, executing hands-on batch reviews, investigations, vendor management and compliance oversight while seamlessly bridging the gap between technical, clinical, and regulatory operations.
Key responsibilities and duties:
•         Ensure procedures and systems are established and maintained to ensure the Company’s compliance with ICH GXP guidelines; current national and international legislation; and relevant regulations, standards and guidelines
•         Spearhead continuous quality improvement activities
•         Oversee the implementation, manage the content, coordination, and execution of our client’s electronic Quality Management System (eQMS).
•         Define and manage the delivery of training programs for employees via the eQMS
•         Coordinate external audits, internal audits and gap analyses
•         Manage the QA oversight of contract manufacturers and testing labs (internal/external) to ensure products/deliverables meet all required quality standards and specifications.
•         Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
•         Lead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.
•         Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
•         Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GXPs.
•         Review CMC documents submitted to regulatory agencies.
•         Develop work instructions and/or standard operating procedures
•         Lead inspection readiness preparation and training
•         Review and approve new procedures, specifications, analytical methods and other quality documentation as required
•         Collaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelines
•         Negotiate and maintain Quality Agreements with GXP service providers
•         Build and maintain strong working relationships with members of the CMC, Regulatory Clinical Operations and Supply Chain teams
Education, qualifications and work experience:
•         B.S. in a science related discipline (preferably in chemistry, biochemistry, or chemical engineering)
•         8+ years related experience in the biotechnology or pharma industry with a sound knowledge and focus on GMP operations, process development/technology transfer validation/ manufacturing/testing/ CMC or equivalent combination of education and experience
•         Knowledge of GCP and experience with clinical operations would be an asset
Demonstrated experience with eQMS Tools, Gantt Charts, Excel Spreadsheets and Project Planning tools, Smartsheet
•         Experience in planning, organizing and conducting audits.
•         Experience in preparing for inspections ideal
•         Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met.
•         Critical thinker, outgoing and enthusiastic and well-organized.
•         Excellent written, spoken, listening and presentation skills and a demonstrated ability to influence within the wider project team at the level of functional leadership.
•         Self-motivated; able to work independently and within a team
•         Excellent time management and multi-tasking skills
•         Maintains a composed, collaborative and independent manner when dealing with issues, challenges, conflicts and opportunities.

Salary Range: $95,000 to $130,000, depending on education and relevant experience
While only short-listed candidates will be notified, we thank each applicant for their submission

About NWRPros

NWRPros is a dynamic and collaborative team of consulting talent solutions professionals with specialties in executive coaching, consulting, executive search, talent acquisition and talent program designs for start-up and fortune 100-500 companies nationally.

Industry expertise includes Biotech, Technology, Healthcare, Engineering and Entertainment.

Notable clients:

Sangamo Therapeutics, Omeros, Seattle Genetics, iStreamPlanet, Temporal.io, Frontier Communications, Disney, Sony, among others.

Corporate Career and Leadership Coaching:

We coach C-level as well as high performing/high potential leaders, individual contributors and mid-level managers.

Developing Coaching Program Design:

• Coaching high potential talent as they navigate the corporate career ladders.

• Team Leadership and Management. Partnering with team leaders and teams - offsites, team building, management for leadership teams, departmental initiatives, new manager development,

• Executive onboarding and other group and collaborative initiatives.

• Developing coaching culture initiatives.

Talent Acquisition Program Development and Project Recruiting

We provide large scale contract project recruiting/sourcing and talent acquisition consulting services to healthcare, technical, scientific and global health non-profit clients.

• Production oriented, hands-on recruiting for scale-up staffing and hard-to-fill positions.

• As a client partner, we provide market assessment and consulting to hiring managers; conduct strategy and progress meetings, provide process outlines, develop candidates, facilitate new hire selection, offer negotiation and onboarding coaching.

Industry

Consulting & Advisory

Company Size

1-10 employees

Headquarters

Unknown

Year Founded

1999

Website

nwrpros.com

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