What are the responsibilities and job description for the Director of Process Validation position at Secure Check?
Description
The Director of Process Validation provides strategic and technical oversight of validation activities performed by external drug substance and drug product (injectables and solid oral dosage forms) manufacturing and testing partners. Operating within a virtual pharmaceutical model, this role ensures that all contract development and manufacturing organizations (CDMOs/CMOs) maintain compliant processes, equipment, utilities, cleaning procedures, and computerized systems in accordance with global cGMP requirements. This position focuses on governance, review, approval, and lifecycle management of validation deliverables rather than direct execution. The Director collaborates cross functionally with Quality, Analytical Chemistry, Supply Chain, External Manufacturing, and Regulatory Affairs to support technology transfers, commercial readiness, deviation management, and regulatory inspections.
Essential Duties And Responsibilities
- The main responsibilities of this role include:
- Provide technical oversight of process, equipment, utility, shipping and cleaning validation executed by external partners.
- Review and approve validation master plans (VMPs), protocols, reports, and lifecycle documents generated by CDMOs.
- Ensure outsourced activities meet internal standards, ICH guidelines, and global regulatory expectations (FDA, EMA, MHRA, etc.).
- Lead and/or evaluate validation risk assessments (FMEA, risk ranking, etc.) in collaboration with CDMOs.
- Define validation acceptance criteria and critical parameters in alignment with QbD principles.
- Ensure CDMOs apply sound scientific rationale, statistical approaches, and data integrity standards.
- Oversee process validation activities performed at contract manufacturing sites.
- Ensure CPPs and CQAs remain in a state of control throughout commercial production.
- Support technology transfers to new manufacturing or testing sites, ensuring validation readiness.
- Review and approve commissioning/qualification documents (URS, FAT/SAT summaries, IQ/OQ/PQ) produced by CDMOs.
Requirements Education and Experience
- Bachelor’s or Master’s degree in chemical or biomedical engineering, or other related life sciences discipline.
- 10 years in validation within pharmaceuticals, biotech, or advanced therapies.
- Knowledge And Skills
- Experience working with or inside CDMOs is strongly preferred.
- Strong understanding of virtual manufacturing models and global CDMO oversight frameworks.
- Demonstrated ability to influence without authority in outsourced environments.
- Experience in aseptic/sterile manufacturing and tableting, of therapeutic peptides, small molecules, biologics, or high potency APIs.
- Knowledge of validation-related processes, Six Sigma, Lean, etc.
- Experience authoring regulatory submissions (e.g., Module 3 validation sections).
- Expertise in ICH Q7/Q8/Q9/Q10, EU Annex 11/15, FDA 21 CFR 210/211.
- Understanding of QbD, risk-based validation, and CPV.
- Capability to evaluate statistical approaches (e.g., process capability, sampling rationale).
- Strong communication and diplomatic negotiation skills with external partners.
- Ability to analyze complex technical data and summarize risks clearly.
- Highly organized, with the ability to manage multiple CDMO interfaces simultaneously.