Senior Specialist, Quality Assurance, Quality Systems & Compliance

Astellas Pharma - Sanford, NC

Full-time - Senior

Sanford, NC

Management of Companies and Enterprises

About the position

The Senior Specialist, Quality Assurance, Quality Systems & Compliance at Astellas Pharma is responsible for supporting the Supplier Quality Management Program. This role involves conducting GMP audits of suppliers and contract manufacturing organizations, managing vendor changes, and ensuring compliance with regulatory requirements. The position requires collaboration with internal stakeholders to maintain quality standards and ensure inspection readiness through adherence to cGMPs and effective management of quality agreements.

Responsibilities

• Establish and maintain expert knowledge on quality systems/regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 600, 211), EudraLex and ICH Guidance.
• Effectively communicate changes in regulatory/compliance requirements to functional groups ensuring understanding and implementation of required actions.
• Facilitate cross-functional team discussions in support of major/critical deviation investigations and change controls.
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices.
• Effectively drive for results and communicate cross-functionally, cross-site.
• Support continuous improvement and drive compliance through gap assessments and compliance changes.
• Lead the execution, maintenance, and periodic review of Quality Agreements with external suppliers/vendors.
• Provide QA oversight throughout the lifecycle of the Vendor Change Notification (VCN) process.
• Support increased inspection readiness activities such as GMP/Compliance Walkthroughs.
• Support internal audits to improve site compliance and inspection readiness.
• Support supplier audits and implement Astellas requirements where applicable.
• Prepare and complete audit reports and communicate results internally.
• Conduct reviews of and maintain the Approved Supplier List.
• Support the preparation, execution, and follow-up activities related to Pre-Approval and regulatory inspections.
• Prepare metrics and provide updates related to supplier quality, audits, and general site compliance.
• Perform other support responsibilities as requested.

Requirements

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 10+ years relevant experience or 8+ years with master's degree.
• Current and working knowledge of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements.
• Proven ability to manage multiple projects while maintaining quality.
• Successful history of working independently with minimal supervision.
• Strong interpersonal skills with a reputation for collaboration with colleagues.
• Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).

Nice-to-haves

• Bachelor's degree with 2+ years of audit management experience or higher education preferred.
• Experience with internal or external auditing.
• ASQ Auditor Certification or equivalent experience.
• Experience working with external partners and management of suppliers.
• Experience in clinical and commercial GMP environments.
• Experience working with Quality systems in support of early, late-stage development, and commercial programs.
• Experience with quality management tools, e.g., Veeva, TrackWise.
• Self-motivated with ability to plan, organize and prioritize multiple tasks.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program