Senior Director Quality

CDC Global Solutions; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

CDC Global Solutions seeks a Head of Quality to lead QA and QC in a growing US CDMO. You will own QMS, ensure inspection readiness, and drive compliance across API development, manufacture, testing and release.

You will manage regulatory interactions with FDA and other authorities, oversee validations, audits, and DMF updates, and mentor a talented quality team to deliver samples that meet global quality standards.

Qualifications

• BS/BA in chemistry or life science required; Master’s degree preferred.
• Familiar with CFR 21 and ICH guidelines related to GMPs.
• Minimum 10 years’ experience in pharmaceutical/biotech with 8+ years in Quality Operations in CDMOs.
• Proven management and project leadership experience.

Responsibilities

• Develop and implement a Quality Management System for GMP development, manufacturing, testing and release.
• Implement and maintain a Quality Risk Management system.
• Ensure activities comply with cGMP, Global Policies and Health and Safety rules.
• Manage customer audits, and prepare/approve Quality Agreements.
• Lead FDA and other Health Authority inspections and inspection readiness programs.
• Oversee validation/qualification activities and approval of protocols/reports.
• Hire, coach and motivate QA/QC staff; provide performance feedback and development.
• Release API intermediates and final API batches.
• Coordinate quality issues with other departments and customers.
• Support CAPEX and Operational Excellence initiatives; draft DMF documents.

Skills

Quality Management

Regulatory Compliance

GxP Knowledge

cGMP Understanding

Education

BS/BA in Chemistry or Life Science

Master’s degree preferred

Job description

CDC is partnering with a global CDMO specialising in APIs, small molecules, peptides and drug product formulation. Backed by significant investment, the business is expanding its US footprint and needs a Head of Quality to lead the next phase.

You’ll own all QA and QC functions on site and make sure the expanded operation is inspection-ready and set up to deliver for customers from day one.

Responsibilities

• Develop and implement an effective Quality Management system for the development, manufacturing, testing and release of commercial and clinical API, by providing direction and guidance to all departments involved in GMP activities.
• Implement and maintain a Quality Risk Management system.
• Ensure that all activities are performed according to cGMP, Global Policies and Health and Safety rules.
• Manage customer audits, prepare, review and approve Quality Agreements
• Manage FDA and other Health Authorities inspections, including the preparation and execution of the inspection readiness program.
• Ensure that all validation/qualification activities are executed according to international standards. This includes the approval of validation/qualification protocol and reports as needed.
• Hire, coach and motivate the quality assurance and Quality Control staff and/or functions. Responsible for providing regular performance feedback, development opportunities.
• Responsible for the release of API intermediate and final API batches.
• Communicate and coordinate with other departments and customers as required for quality related issues.
• Support the site in CAPEX and Operational Excellence initiatives.
• Responsible for elaboration of regulatory CMC strategies to support development and lifecycle of APIs and drug products in USA, EU, emerging countries, and ROW.
• Escalate to Global Quality organisation critical events as per global procedure.
• Help to draft and update annually DMF documents.

Qualifications

• The successful candidate must be able to work on multiple projects with a minimum of supervision and meet established timelines.
• Qualified candidate should have a BS/BA in chemistry or life science. Master’s degree preferred.
• A minimum of 10 years’ experience in Pharmaceutical, Biotech, or related industry required with at least 8 years in Quality Operations in CDMO organisations.
• Be familiar with both CFR 21 and ICH guidelines in regard to GMPs’.
• Previous management and project experience is required.
• Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
• Computer skills in MS Word, EXCEL, and Access are desirable.
• Must possess strong interpersonal and communication (written and oral) skills.