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Invivyd · 12 hours ago

Associate Director, Quality Assurance Operations

New Haven, CT (Northeast Preferred)

Full-time

Hybrid

Lead/Staff, Director/Executive

10+ years exp

Invivyd is dedicated to delivering protection from serious viral infectious diseases, focusing on innovative antibody candidates. The Associate Director of Quality Assurance Operations will oversee compliance with GMP regulations, collaborate with various departments, and ensure the effectiveness of the Quality Management System while managing vendor relationships and regulatory inspections.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Review and approve relevant GMP documents for compliance to Invivyd’s Quality Management Systems and Health Agency regulations, including but not limited to: specifications, batch manufacturing records, stability protocols/reports, methods, and process validation documents

Work collaboratively with Manufacturing and Supply Chain counterparts to facilitate timely and effective resolution of process deviations, investigations, CAPAs, and batch record reviews, and to facilitate timely batch release/disposition to meet clinical and/or commercial needs

Participate in audits of GMP service providers according to appropriate Invivyd Quality Management System and regulatory requirements

Conduct Quality Management Review meetings with Executive Management to review the suitability and effectiveness of the Quality Management System

Create/revise SOPs as appropriate, including keeping up with SOP Periodic Review requirements

Upgrade Vendor Management Program by authoring/revising QA procedures as appropriate

Develop internal and external audit schedules and execute per audit plan

Apply Risk Management principles to qualification and oversight of external service providers

Participate in and manage regulatory inspections, including presenting and defending the GMP Vendor Management Program in regulatory inspections

Maintain current knowledge of GMP regulations and guidances, in particular, regulatory intelligence regarding vendor management expectations

Provide ongoing guidance and ensure compliance with established systems, process, and procedures

Assist in the development, implementation, and maintenance of GMP training and compliance programs for all company personnel involved in GMP activities

Partner with stakeholders on maintenance and implementation of other training across the organization (i.e., Clinical Quality Assurance, IT, HR, Finance, Corporate Compliance, Medical Affairs) to ensure full compliance

Qualification

Biological GMPsQuality AssuranceVendor ManagementRisk ManagementBiologics manufacturingRegulatory complianceQuality SystemsCommunicationProblem-solving skillsAttention to detail

Required

A bachelor's degree in a scientific discipline or biotechnology field

Minimum of ten years of experience in pharmaceutical industry with a minimum of five years in Quality Assurance, or masters/doctorate degree with commensurate level of experience

Strong knowledge and experience with ICH, USP, 21 CFR 210, 21 CFR 211, 21 CFR 600, and EMA regulations including vendor management

Expertise in applying GMPs for Development, Clinical Supplies, and Commercial Drug Substance and Drug Products

Extensive hands-on experience in: Biologics manufacturing and Quality Assurance

Vendor Management (qualification audits, quality agreements, relationship building) and presenting and defending Vendor Management program during regulatory inspections

Exception Management (deviation investigations, CAPA development, Change Control)

Product Complaints Management

Planning and conducting internal and external audits, authoring audit reports, and follow up on CAPA implementation and Risk Assessment to guide level of QA audits and oversight

Ability to proactively identify and determine impact of issues on GMP compliance and product development and commercialization and company needs

Ability to interpret GMP regulations appropriate for the phase of drug development

Ability to multi-task and adjust to changing priorities

Excellent written and oral communication and organizational skills

Ability to communicate complex information in a virtual environment

Strong attention to detail and good problem-solving skills