Senior QA Specialist External Manufacturing

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

A global biotechnology company is seeking an experienced Senior QA Specialist to oversee a Contract Manufacturing Organization (CMO) operating under aseptic manufacturing conditions.

This role will support quality compliance and operational excellence across sterile fill-finish, vial filling, labelling and packaging activities. Working closely with external manufacturing partners and internal stakeholders, you will help ensure the quality and safety of products supplied to patients worldwide.

Reporting to the Head of QA for External Manufacturing, you will join a collaborative international QA team.

Key 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.

Qualifications and experience

• 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.

This is an opportunity to take on a broad and impactful QA role within an established biotechnology organisation. You will work with an experienced international team, contribute to a strong quality culture and support the delivery of products that make a meaningful difference to patients.