Product Quality Compliance Specialist (CMC)

About the Role

BioSpace is seeking a Product Quality Compliance Specialist to support Chemistry, Manufacturing, and Controls (CMC) activities. This role serves as a quality representative for product and distribution compliance for commercial programs, including support with Product Quality Reviews (PQR). The position supports the development, coordination, and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts, and overseeing product management activities.

This role works collaboratively with CMC team members, alliance partners, collaborators, and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

Location: Rensselaer, New York, United States

Work Model: Monday-Friday, 8:00 AM - 4:30 PM

Key Responsibilities

• Oversees the global change management implementation plan.
• Supports the evaluation of impact of proposed process changes, deviations, and CAPAs on the end-to-end supply chain.
• Oversees the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
• Assesses quality-related information to detect trends and works with subject matter experts to determine the need for actions required in response to those trends.
• Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
• Interacts with global regulatory authorities in support of CMC activities during Agency inspections.
• Collaborates cross-functionally to support regulatory release process and inventory review.
• Executes relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
• Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
• Supports launch readiness and distribution compliance by ensuring appropriate GMP source documentation is in place to support regulatory activities, and launch material is aligned with the applicable regulatory dossiers.
• Provides writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR), clinical notice of events, and agency inspection responses in collaboration with CMC RA, QA, and SMEs.
• Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT, and SMEs.

Requirements & Tech Stack

• BS/BA in Chemistry, Biology, or related field.
• Experience in pharmaceutical or medical device industry.
• Experience with supervisory and/or leadership.
• Chemistry, Manufacturing, and Controls (CMC)
• Product Quality Reviews (PQR)
• Global regulatory change management
• CAPAs
• GMP
• Regulatory
• Quality
• Manufacturing
• Supply
• Change controls
• BPDR, QDR, PDR
• CARRs

Qualifications

Qualifications vary based on the specific role level (Assoc QA Specialist, Specialist, Sr Specialist).

• Assoc QA Specialist: Minimum of 0-2 years relevant experience or equivalent combination of education and experience.
• Specialist: Minimum of 2 years relevant experience or equivalent combination of education and experience.
• Sr Specialist: Minimum of 5 years relevant experience or equivalent combination of education and experience.