Role Summary

We are seeking a Director of Quality Assurance (QA) who will play a pivotal role in ensuring the quality and compliance of our operations related to vendor qualification and computer system validation. This position will be responsible for managing the assessment and qualification of GXP vendors and ensuring a validated state of GXP computer systems used at Apogee. This position requires a strategic mindset, strong leadership capabilities, ability to be flexible and collaborative, and possess an in-depth knowledge of GXP regulatory requirements in the biotech industry.

Key Responsibilities

Vendor Assessment and Qualification:

• Develop and maintain a comprehensive GXP vendor qualification program in accordance with company procedures and regulatory standards.
• Collaborate with the relevant QA Heads (Clinical QA and GMP QA) to evaluate potential vendors through risk assessments, vendor assessments, audits, and performance evaluations to ensure vendors meet quality and compliance requirements.
• Oversee the execution of vendor qualification activities, including documentation review (e.g., vendor questionnaires), agenda preparation, report review and approval, response review, and assessment/audit closure.
• Perform vendor assessments, including audits, in accordance with company procedures and regulatory standards.
• Maintain the Apogee GXP vendor audit schedule and vendor list.
• Negotiate quality agreements, as required, with GXP vendors.
• Establish and maintain strong relationships with vendors, fostering effective communication and collaboration to drive continuous improvement.
• Lead the implementation of the Veeva Vault Vendor/Supplier Management module.

Computer System Validation:

• Lead the computer system validation (CSV) program, ensuring that GXP systems that are directly managed by Apogee are validated and maintained in compliance with regulatory requirements, including US FDA 21 CFR Part 11 and EU Annex 11.
• Collaborate with cross-functional teams to execute validation activities, including system risk assessments, requirements definition, testing, and final validation reports.
• Lead lifecycle management of Apogee GXP systems, including change management (computer system change control and re-validation, if applicable).
• Track and complete computer system change controls to implement system improvements while maintaining a validated state.
• Track and conduct periodic user account and system audit trail reviews.
• Maintain the Apogee GXP validated system list.
• Provide guidance on data integrity principles and ensure that computerized systems are secure, reliable, and capable of producing accurate and traceable data.

Ideal Candidate

• A Bachelor's or Master's degree in a relevant scientific discipline or equivalent
• A minimum of 10 years of experience in GXP quality assurance within the biotech or pharmaceutical industry, with progressive leadership experience
• American Society for Quality (ASQ) Certified Quality Auditor
• In-depth knowledge of GXP regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience and knowledge of medical device Quality System Regulations preferred
• Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
• Strong leadership, communication, and interpersonal skills with the ability to influence and drive change
• Excellent problem-solving and critical thinking abilities
• Ability to manage multiple projects with aggressive timelines and changing priorities
• Ability and willingness to travel up to 15% (approximately 5-8 times per year for company meetings)

The anticipated salary range for candidates for this role will be $210,000-$230,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.