Joe Hernandez

Sr. Director Quality and Compliance

Executive Summary & Candidate Overview

Joe is a highly experienced quality professional with over three decades of experience in GMP compliance across multiple industries within the life sciences sector. He possesses a strong background in overseeing quality assurance, supplier management, regulatory compliance, and manufacturing operations. Joe's track record of success in implementing and maintaining robust quality management systems demonstrates his ability to drive excellence and ensure regulatory adherence in dynamic and highly regulated environments.

Accomplishments and Key Skills

Joe's key accomplishments and skills include:

Overseeing GMP compliance efforts to develop, establish, and maintain QA programs, policies, and procedures, ensuring cGMP compliance with internal SOPs and applicable regulations.
Leading quality projects and cross-functional teams to implement quality systems, infrastructure improvements, and regulatory requirements.
Managing supplier quality management systems, external manufacturing, testing, and storage/distribution suppliers to ensure compliance with quality and regulatory requirements.
Establishing and executing audit schedules of current and potential suppliers, conducting audits, and driving continuous improvement initiatives.
Reviewing and approving manufacturing batch records, analytical records, technical documents, and batch documentation for disposition.
Providing quality guidance and support for change controls, CAPAs, investigations, and regulatory filings for drug products.
Maintaining current knowledge of industry standards and regulatory requirements for pharmaceutical quality management systems.

Location and Travel

Open to: On-site and remote roles.
Remote Roles: Experienced in remote work and collaboration.
Compensation Seeking: Open to discussing compensation details based on role and responsibilities.
Position Seeking: Seeking leadership roles in quality assurance, compliance, and manufacturing operations within the life sciences industry.

Work Experience

Senior Director Quality and Compliance - Stason Pharmaceuticals
- Lead GMP compliance efforts, managed QA programs, policies, and procedures, and provided QA/GMP guidance to operational department heads.
- Oversaw quality projects, managed vendor qualification programs, and conducted internal audits for cGMP compliance.
Director of Quality Assurance and Compliance - Evolus, Inc.
- Supported supplier quality management systems, managed external manufacturing, testing, and storage/distribution suppliers, and ensured compliance with quality and regulatory requirements.
Head of Quality and Compliance - HBT Labs
- Overseeing cGMP compliance of parenteral manufacturing and testing operations, managed quality systems, and audited external and internal suppliers.
Manager QA/QC Clinical and Commercial CMC and Quality Systems - Spectrum Pharmaceuticals
- Overseeing cGMP compliance of contract manufacturers and testing laboratories, providing quality support for manufacturing operations, and conducting cGMP audits.
Manager Supplier Quality, Medical Device Quality Compliance - Penumbra, Inc.
- Managing supplier qualification programs, audit programs, and supplier-related quality issues, and implementing quality agreements and change evaluation programs.
Technical Manager, Supply and Distribution Quality - Genentech, Inc.
- Managing supplier initiated change controls, discrepancies, and investigations, and participating in audits of suppliers.
Manager QA, Contractor Oversight and Lot Disposition - Anesiva, Inc.
- Building and maintaining relationships with CMOs and suppliers, managing contract operations, and coordinating audits of CMOs and suppliers.
Senior QA Auditor - Amylin Pharmaceuticals
- Conducting cGMP audits of CMOs and raw material suppliers, performing internal and external audits, and interpreting FDA and international regulations.
QA Compliance Specialist - Ligand Pharmaceuticals
- Overseeing contract manufacturing and materials suppliers, performing batch history record review, and maintaining changes and deviations to support annual product review.
QC Senior Biochemist - IDEC Pharmaceuticals Corp.
- Validating assays and equipment, maintaining and operating laboratory analytical equipment, and reviewing release data.