Senior Quality Assurance Lead – Pharma, Compliance & QMS

Actalent

Illinois

On-site

USD 120,000 - 140,000

Full time

14 days+

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Benefits offered by this job

Health insurance

401(k)

Dental insurance

Vision insurance

PTO

10% STI incentive

Job summary

Actalent in Morton Grove, IL is seeking a Manager of Quality Assurance to lead the SQE organization and ensure pharmaceutical manufacturing, testing, and distribution meet stringent regulatory and quality standards.

You will collaborate with T&D, Engineering, Operations, and external customers and vendors to support the full lifecycle of GxP systems, driving continuous improvement and strong quality metrics across functions.

Qualifications

10+ years of progressive experience in pharmaceutical or biotech Quality Assurance, with a preference for experience with small-molecule/API.
Strong working knowledge of FDA, EMA, and other global regulatory standards.
Experience in both commercial and development phases of pharmaceutical products, including clinical development, manufacturing, and post-market activities.
Demonstrated experience in autonomous and collaborative team environments, with a track record of managing change in complex, fast-paced settings.
Ability to prepare for and manage internal and external audits, including investigator sites, CROs, and vendors.
Experience developing, implementing, and maintaining a Quality Management System (QMS) in compliance with cGMP, ICH, and other standards.
Oversight of CAPA (Corrective and Preventive Action), deviation management, change control, and training systems.
Experience with risk management, design control, and supplier qualification audits.

Responsibilities

Develop and implement quality policies, standards, and systems aligned with the organization’s mission and regulatory obligations.
Set measurable quality objectives and integrate quality into the plant’s culture.
Communicate the importance of quality to all stakeholders, including management, employees, and suppliers.
Lead the QA team, including hiring, training, and performance evaluation.
Oversee inspection preparations and respond to internal and external audits.
Conduct investigations into deviations, non-conformances, and CAPA (Corrective and Preventive Action) processes.
Monitor supplier quality and manage vendor contracts.
Lead initiatives to improve process efficiency, product quality, and compliance.
Maintain and update the quality management system and quality metrics reporting.
Collaborate with R&D, production, supply chain, and regulatory affairs to ensure quality is embedded in all processes.