Senior Specialist/Manager QC, External Manufacturing

The RFT Group; Ireland; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work

Contract role (12+ months)

Job summary

The RFT Group in Ireland is seeking a Senior Specialist/Manager Quality Control for External Manufacturing to provide technical/quality oversight at contract testing laboratories and CMOs, ensuring GMP compliance and successful regulatory outcomes.

The role focuses on Biologics Drug Substance/Drug Product QC, analytical transfer/validations, and ongoing support for manufacturing/process validation, with potential to extend beyond 12 months and option for hybrid/remote work.

Qualifications

• 6+ years of experience in a pharma lab/quality environment.
• Experience in Biologics QC testing and method validation/transfers.
• Knowledge of FDA/EU guidelines for analytical testing and manufacturing.
• Experience with regulatory inspections and dossier submissions.

Responsibilities

• Manage stability programs for External Manufacturing products.
• Resolve OOS/OOT analytical deviations.
• Provide analytical/technical support to Technical Operations and CMOs.
• Ensure cGMP compliance in external testing labs.
• Support analytical method transfers and validation programs.
• Lead CAPA/Deviations/LIRs under QMS.
• Author/Review SOPs, validation protocols and reports.
• Maintain QC metrics and KPIs.
• Oversee product trending at release and stability.
• Support QC systems improvements and continuous improvement programs.

Skills

Biologics QC testing

Method validation/transfers

Regulatory inspections experience

Quality systems knowledge

Interpersonal skills

Education

BSc/MSc in biology/chemistry

Tools

LIMS

Job description

Our client, a global Biopharma company with strong product pipeline and commercial products, now have approval to hire a Senior Specialist / Manager Quality Control for External Manufacturing, who will provide technical / quality oversight at contract testing laboratories and external manufacturing operations.

About the Role

This hire will provide support for all aspects of QC operations at CMOs for Biologics Drug Substance Drug Product ensuring GMP compliance and ensures successful outcomes from Health Authorities inspections/regulatory submissions.

This Senior Specialist / Manager QC, External Manufacturing role is a 12-month contractor (with potential to roll on for at least another 12 months).

This hire will be resident in Ireland with legal authorisation to work from here on a full-time basis. There is flexibility to work hybrid basis or remotely within Ireland.

The ideal candidate will have extensive experience with analytical transfer/validations for biologics drug substance/drug product and experienced in ongoing analytical support for routine manufacturing/process validation activities. Experience with CMC/regulatory submissions would be distinct advantage.

Responsibilities

• Management of stability programs for assigned products in External Manufacturing Operations
• Resolution of out-of-specification (OOS)/out of trends (OOT) analytical deviations
• Provide analytical/technical support to internal Technical Operations and External Manufacturing
• Ensure that operations within External Manufacturing testing laboratories are compliant with cGMPs regulatory filings.
• Support analytical method transfers/validation programs in compliance with regulatory and Pharma company requirements
• Troubleshooting of analytical methods used in testing of Biologics Drug Substance/Drug Product
• QMS for CAPA/Deviation/LIRs, training and quality compliance
• Author, Review and approval of SOPs, analytical validation protocols and reports.
• Maintain Quality Control Metrics/KPIs as directed
• Product trending programs for assigned products at release and stability
• Support the creation and maintenance of regional and global QC and laboratory systems in relation to quality control operation.
• Actively support QC system improvements to ensure efficient, effective and compliant process
• Identify and implement Continuous Improvement programs as appropriate within Pharma

Qualifications

• BSc, MSc or equivalent in biology, biochemistry, chemistry or a related science discipline

Required Skills

• 6+ years’ experience working in a laboratory/quality environment within the pharmaceutical industry
• Experience in Biologics QC testing, method validation/transfers for drug substance/drug product
• Demonstrated knowledge of quality systems, FDA and EU guidelines as the relate to analytical testing and drug substance/product manufacturing
• Experience with regulatory inspections/dossier submissions
• Strong Interpersonal skills and professional skills to interact at all levels including peers, senior management and CMOs

Preferred Skills

• Extensive experience with analytical transfer/validations for biologics drug substance/drug product
• Experienced in ongoing analytical support for routine manufacturing/process validation activities
• Experience with CMC/regulatory submissions would be distinct advantage

Pay range and compensation package

Not specified.

Additional Information

• Travel Requirements: <10%