Dave Mcnally Email & Phone Number

Cork, IE

Cork, County Cork, Ireland

• Commanded a team of 8 in delivering Quality Assurance oversight for BioMarin’s pre-commercial products within Global External Operations (GEO).
• Attained successful IND stage for 2 pre-clinical products, 2 tech transfers to CMOs, and a new product introduction within 18 months.
• Spearheaded QA validation for all shipping, major changes/deviations, MRBs and process validation activities in GEO for rigorous quality standards and compliance.
• Advocated for quality on the GEO Operations Leadership Team (OLT), driving strategic initiatives that ensured the timely delivery of high-quality products to patients.
• Provided critical input as a Clinical QA steering team member, defining and supporting requirements for Clinical QA within GEO.
• Drove a value realisation project, delivering $5M in savings for GEO through strategic quality initiatives and process optimisations.

Cork, County Cork, Ireland

• Directed a team of 11 overseeing process validation at multiple CMO sites.
• Scheduled process validations valued at over $18M for drug substance, drug product (fill/finish), and secondary packaging for 3 new commercial products across 6 CMOs.
• Defined and executed comprehensive validation strategies, administering planning, execution, and reporting for technology transfers, new product introductions, and existing commercial products.
• Masterminded shipping validation for biologics, small molecules, gene therapy, and combination device products to meet rigorous standards for various global market conditions.

Shanbally, Ringaskiddy, Cork

• Established and led a new global validation team within quality, managing 5 direct reports for packaging validation activities at CMO sites in Europe and the US.
• Steered the successful packaging validation for BioMarin’s first gene therapy product, process validation for serialisation across 8 CMOs for EU and US markets, and equipment qualification and process validation of a.
• Pioneered the deployment of new process for shipping validation for all BioMarin products, covering all stages of the global supply chain for both clinical and commercial supply, including the global policy.
• Introduced and managed a periodic revalidation evaluation process for the ongoing validation status of all legacy shipping configurations.

Shanbally, Ringaskiddy, Cork

• Executed validation oversight for the employment of innovative secondary packaging processes at CMO sites across Europe and the US.
• Integrated a new API site into the supply chain while introducing serialisation at 8 CMO sites.
• Championed the review and approval process for validation plans, process qualification (PQ) protocols and reports, and process validation (PV) protocols and reports.
• Rolled out validation efforts for the introduction, qualification, and process validation of a cutting-edge secondary packaging line and the validation of a new Fed-Batch Manufacturing process.
• Piloted commissioning, planning, Site Acceptance Testing (SAT), Factory Acceptance Testing (FAT), Installation & Operational Qualification (IQ/OQ), and Process Qualification (PQ) for new systems.

Cork, County Cork, Ireland

• Spearheading the development of long-term strategies for Global Quality in alignment with corporate objectives while reporting directly to the SVP, Chief Quality Officer.
• Governing the effective operation of the Global Quality Leadership Team (QLT) as the CQO’s Chief of Staff by boosting optimised business processes for peak performance with annual budget of over $1M.
• Championing several key strategic initiatives for global quality, including quality network strategy, value realisation, and quality cycle time reduction.
• Collaborating with operational excellence to lead and drive continuous improvement projects by executing the Global Quality Communication strategy and enhancement.
• Conceiving and launching an engagement strategy for global quality, successfully operationalising the extended QLT to execute engagement initiatives.

Kalundborg

Commissioning, Qualification & Validation of Utensil Washing Systems & Dry Heat Sterilisers.

Dun Laoghaire

Validation Execution Line Lead for a new syringe, vial and pen packaging line. I conducted FAT's at vendor sites and then during SAT's at Amgen I led the commissioning, qualification and validation of the line for the validation team.

Cork

Supplier Quality Engineering Lead for Packaging supporting day-to-day Quality issues.Introduction & validation of new products at Supplier sites (PPAP).

Cork

Project Lead for Site Measurement Systems Analysis (MSA) Remediation Project.Ownership of Project plan to ensure compliance to corporate remediation schedule.Product Risk Assessment & selection of priority studies.Authoring and executing MSA Protocols & Reports (Gage R&R).Validation SME for Cleaning & Packaging Equipment Qualification (IQ/OQ) and.

Cork

Supplier Quality Engineering Lead for Packaging supporting day-to-day Quality issues.Introduction & validation of new products at Supplier sites (PPAP).Project Lead for Site Measurement Systems Analysis (MSA) Remediation Project.Ownership of Project plan to ensure compliance to corporate remediation schedule.Product Risk Assessment & selection of priority.

Cork

Review and approval of validation protocols for equipment qualification and process validation. I wrote and delivered training modules in risk assessment and the use of FMEA.

Validation SME for Validation Remediation Project.Process characterization and process improvements to reduce waste and downtime.Authoring & executing All Validation documentation: Validation Plan, URS, FAT, IQ/OQ/PQ Protocols, RTM’s & Reports.

Loughborough

Senior Process Engineer for Solid Dose Manufacturing.Investigation and resolution of daily processing issues for tablet and capsule manufacture and packaging.Process characterization and process improvements to reduce waste and downtime.Authoring & executing All Validation documentation: Validation Plan, URS, FAT, IQ/OQ/PQ Protocols, RTM’s & Reports.

Loughborough

I led Problem Solving initiatives, Root Cause Analysis of Production quality issues and Preventive Action implementation (CAPA).Lead cGMP Risk Assessment teams through Process Mapping, FMEA and process improvementscGMP Compliance & Product Quality Assurance.Authoring and reviewing Procedures, Work Instructions and SOP’sPerform internal Quality Assurance.

Bachelor Of Engineering (B.Eng.), Electrical And Electronics Engineering

Education record