Director Quality Assurance

Qpex Biopharma•San Diego, CA

6h•$200,000 - $240,000

About The Position

Overview The Director Quality Assurance provides strategic and operational leadership for Quality Assurance across Qpex’s multi-therapeutic, multinational Phase 1–3 infectious disease development programs. This role is responsible for designing, implementing, and overseeing robust global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP requirements. Working closely with executive leadership, Regulatory Affairs, Shionogi Quality partners, CMOs, and external consultants, this role ensures quality oversight across development, manufacturing, testing, and product release activities. The position leads internal teams and external vendors, supports regulatory submissions and inspections, and drives continuous improvement of quality systems to enable successful regulatory approvals and commercialization. Detailed Description Primary Duties and Responsibilities include: Direct multi-therapeutic, multi-national quality assurance oversight in Phase 1-3 drug development programs as part of the Qpex Infectious Disease team. Oversee quality systems in consultation with CEO, Shionogi Quality Groups, Qpex CMO, Clinical Operations, GMP staff and external consultants. Development of project and budget plans, integrating team structures, developing a Quality Assurance Plan, Clinical Quality Plan and initiating quality systems across disciplines. Establish Quality Assurance Programs matched with regulatory requirements and the appropriate stage of product development. In conjunction with regulatory affairs, assist in the writing and assembling of CMC sections of regulatory submissions including IND, CTA and IMPDs. Follow applicable regulations, including FDA, ICH, Qpex and Shionogi Policies and Procedures. Responsible for the Selection, oversight and Audit of Contract Vendors to ensure compliance in product development. Perform comprehensive internal and external Compliance Audits according to GLP, GCP, GMP and Quality Systems requirements. Provide Quality Assurance oversight of development, manufacturing, validation, testing, and product release activities. Prepare documentation and train staff for Pre-Approval Perform Assessment, Gap Analysis, and Improvement of Quality Assurance Systems to prepare for successful regulatory inspections. Training of Staff in regulatory and compliance procedures. Responsible for oversight, review, and approval of internal controlled documents. internal sponsor SOP reviews and corresponding training. Ensured CROs and study sites activities and documentation were in accordance with sponsor SOPs. Responsible for clinical trial material (IP) labeling approval (US and global studies); coordinate proposals, review and ordering of packaged and labeled IP with external vendors. Supervisory Responsibilities Manages external consultants in the Qpex Quality Assurance Department. Is responsible for the overall direction, coordination, and evaluation of these employees and consultants. Carries out supervisory responsibilities in accordance with the organization's policies and applicable.

Requirements

BS or advanced degree in Biology or Life Sciences plus at least 10 years of proven successes in research and the pharmaceutical, medical device, and biotechnology industries.
Experience in global quality systems with broad experience from R & D to product launch and commercialization.
Highly successful record in establishing, building, and executing quality systems.
Demonstrated competence in regulatory knowledge and compliance, and regulatory interactions.
Managed CMC, product approval process, launch activities and compliance of products for U.S. and Europe resulting in successful regulatory submissions and product approvals.
Excellent verbal and written communication skills and professional presentation skills.
A demonstrated record of scientific accomplishments and a proven ability to achieve results, experience supervising personnel and projects, excellent knowledge of GCP, ICH and GMP guidelines.

Responsibilities

Direct multi-therapeutic, multi-national quality assurance oversight in Phase 1-3 drug development programs as part of the Qpex Infectious Disease team.
Oversee quality systems in consultation with CEO, Shionogi Quality Groups, Qpex CMO, Clinical Operations, GMP staff and external consultants.
Development of project and budget plans, integrating team structures, developing a Quality Assurance Plan, Clinical Quality Plan and initiating quality systems across disciplines.
Establish Quality Assurance Programs matched with regulatory requirements and the appropriate stage of product development.
In conjunction with regulatory affairs, assist in the writing and assembling of CMC sections of regulatory submissions including IND, CTA and IMPDs.
Follow applicable regulations, including FDA, ICH, Qpex and Shionogi Policies and Procedures.
Responsible for the Selection, oversight and Audit of Contract Vendors to ensure compliance in product development.
Perform comprehensive internal and external Compliance Audits according to GLP, GCP, GMP and Quality Systems requirements.
Provide Quality Assurance oversight of development, manufacturing, validation, testing, and product release activities.
Prepare documentation and train staff for Pre-Approval Perform Assessment, Gap Analysis, and Improvement of Quality Assurance Systems to prepare for successful regulatory inspections.
Training of Staff in regulatory and compliance procedures.
Responsible for oversight, review, and approval of internal controlled documents. internal sponsor SOP reviews and corresponding training.
Ensured CROs and study sites activities and documentation were in accordance with sponsor SOPs.
Responsible for clinical trial material (IP) labeling approval (US and global studies); coordinate proposals, review and ordering of packaged and labeled IP with external vendors.
Manages external consultants in the Qpex Quality Assurance Department.
Is responsible for the overall direction, coordination, and evaluation of these employees and consultants.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable.