Principal Associate II, Quality Assurance Operations

Replimune•Framingham, MA

3d•$134,000 - $173,500•Onsite

About The Position

The Principal Associate I/II, Quality Assurance reports to the Director, Quality Assurance and is responsible for proactively support GMP compliance focusing on Quality processes specific to product disposition of Bulk Drug Substance, Drug Product and Final Drug Product both internal as well as within Contract Labelling and 3PL facilities. This role will require adaptability to function within an internal and external capacity, supporting relationships with internal stakeholders, contract manufacturing organizations (CMOs), suppliers, 3PL (third party logistics suppliers) and clinical trial sites. This position requires a depth of understanding and significant experience in GxP, quality, communication skills and business acumen to conduct responsibilities autonomously. The Principal Associate I/II is responsible for providing support to ensure continuous supply of investigational medicinal products and/or commercial products with GxP relevant international regulations and other This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or engineering.
A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH guidelines.
Demonstrated knowledge and direct experience with Quality Systems and GxP compliance within a regulated environment.
Experience managing quality events (i.e. Deviations, CAPA).
Excel, PowerPoint, Word, SmartSheets proficient
Experience revising procedures and documents.
Excellent attention to detail.
Excellent verbal and written communication and presentation skills across all levels.
Prioritize and manage multiple priorities and projects with little assistance.
Familiarity with clinical and commercial supply areas and processes

Nice To Haves

Experience managing product complaints is preferred.
Experience with Master Control, Veeva or eQMS systems preferred.

Responsibilities

Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness.
Manage/coordinate internal and external batch release for GMP lots, through batch disposition and subsequent release and issuance of Certificate of Analysis / Conformance.
Manage Product Complaints for Commercial Product
Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process.
Reviewing packaging master batch records, packaging, labeling for investigational medicinal product.
Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events.
Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance, including a summary of findings for any batch that does not meet the standard requirements for final disposition.
Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Oversee progression of batch related Out of Specification investigations and deviations to ensure timely progression for release.
Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities.
Lead, mentor and coach quality assurance personnel through development of training to support batch release activities/processes.
Support internal/external batch release audits as Subject Matter Expert.
As assigned