Senior QA Lead, External Manufacturing (Aseptic)

Skills Alliance; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Skills Alliance, a global biotechnology company, seeks an experienced Senior QA Specialist to oversee a Contract Manufacturing Organization operating under aseptic manufacturing conditions.

This role supports quality compliance and operational excellence across sterile fill-finish, vial filling, labelling and packaging, working with external partners and internal stakeholders to ensure product quality and patient safety.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering or a related discipline.
• At least 10 years of Quality Assurance experience in pharmaceutical or biotechnology manufacturing.
• At least five years of experience in aseptic processing and sterile manufacturing environments.
• Demonstrated experience overseeing CMOs or CDMOs is essential.
• In-depth understanding of FDA cGMP regulations, EU GMP Annex 1, sterile fill-finish operations, validation and contamination control strategies.
• Hands-on experience reviewing batch documentation and managing deviations, investigations and CAPAs.
• Excellent communication, organisation and stakeholder management skills.
• Ability to travel periodically to manufacturing sites within the US and internationally, as required.

Responsibilities

• Provide ongoing QA oversight of external manufacturing partners, ensuring compliance with cGMP requirements and Quality Agreements.
• Serve as the primary QA liaison between the company and the CMO.
• Manage and resolve complex quality issues relating to aseptic processing, vial filling, labelling and secondary packaging.
• Review and approve GMP documentation, including batch records, deviations, CAPAs, change controls, validation protocols and reports.
• Support Qualified Persons and internal stakeholders with documentation and quality assessments required for product release.
• Ensure compliance with FDA cGMP, EU GMP, ICH guidelines and applicable US regulatory requirements.
• Participate in risk assessments and investigations relating to sterile manufacturing operations.
• Support technology transfers and process validation at external manufacturing sites.
• Lead or participate in internal and external GMP audits.
• Monitor quality metrics and drive continuous improvement with manufacturing partners.
• Collaborate with Manufacturing, Supply Chain, Regulatory Affairs and Technical Operations.
• Represent QA External Manufacturing in global and cross-functional forums.

Skills

Quality Assurance

Aseptic processing

CMO/CDMO oversight

Regulatory knowledge

Stakeholder management

Education

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering or a related discipline

Job description

Skills Alliance, a global biotechnology company, seeks an experienced Senior QA Specialist to oversee a Contract Manufacturing Organization operating under aseptic manufacturing conditions.

This role supports quality compliance and operational excellence across sterile fill-finish, vial filling, labelling and packaging, working with external partners and internal stakeholders to ensure product quality and patient safety.