Senior QA Officer

A leading, global pharmaceutical manufacturing business is seeking an experienced Validation Engineer to support delivery of a major site validation and capital programme on a 12-month contract.

This is a high-impact role within a busy engineering environment, offering exposure across equipment, utilities, facilities, and laboratory systems, with a need for hands-on execution specialists. If this capability brings with it project lead experience, this will also be valued.

 

The Role

Working as part of the Engineering function, you will support delivery of a structured site-wide validation programme, alongside capital project activity.

Responsibilities will include:

• Supporting delivery of the Site Validation Master Plan (SVMP)
• Generating and reviewing validation / qualification documentation (IQ/OQ/PQ, FAT/SAT, etc.)
• Leading or supporting execution of validation activities across manufacturing, lab, and utility systems
• Working closely with internal stakeholders to ensure GMP and regulatory compliance
• Reviewing vendor documentation and supporting supplier-led validation activities
• Participating in FATs and site-based commissioning activities where required
• Managing or supporting third-party contractors and vendors
• Owning change controls, deviations, and CAPAs linked to validation activities
• Supporting requalification, new equipment introduction, and decommissioning activities

 

Project / Programme Exposure

In addition to core validation delivery, there is scope to contribute at a more strategic level:

• Supporting or leading capital project delivery (GxP and non-GxP)
• Defining project scope, timelines, and deliverables
• Managing project risks, budgets, and progress reporting
• Coordinating cross-functional stakeholders and teams
• Driving project governance, change management, and close-out activities

 

What We’re Looking For

We’re open to a range of profiles, from strong delivery-focused CQV engineers to more senior, project-led professionals:

• Experience in validation / CQV within GMP-regulated environments (pharma / biotech / related)
• Strong understanding of validation principles across equipment, utilities, or facilities
• Experience authoring and executing validation documentation
• Ability to work effectively across cross-functional teams and stakeholders
• Confidence operating in a fast-paced, project-driven environment
• Strong communication and problem-solving skills

We are seeking an experienced Head of Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents across all phases of drug development.

This role provides scientific and operational leadership for medical writing activities, supporting early- through late-stage programs and global regulatory submissions. The Head of Medical Writing will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, and Safety to ensure accurate, timely, and compliant documentation.

 

Key Responsibilities

• Serve as the medical writing lead across one or more clinical programs
• Lead and/or author clinical documents including protocols, CSRs, and Investigator’s Brochures
• Support global regulatory submissions (INDs, NDA/BLA/MAA, health authority briefing documents, CTD Modules 2 and 5)
• Oversee timelines, coordinate cross-functional input, and ensure scientific accuracy and regulatory compliance
• Establish and maintain writing standards, templates, and best practices
• Facilitate efficient review cycles and ensure consistent scientific messaging across documents and programs
• Drive quality, process improvement, and scalable medical writing operations

 

Qualifications

• Advanced degree in life sciences (PhD, PharmD, MD, or MSc)
• 7–8+ years of medical writing experience in pharma, biotech, or CRO settings
• Strong experience across multiple phases of clinical development and global regulatory submissions
• Proven leadership in complex writing projects and cross-functional environments
• In-depth knowledge of ICH, GCP, and global regulatory requirements
• Experience in oncology, rare disease, or other complex therapeutic areas preferred

~20 Hours/Week

We are seeking a highly experienced biostatistical consultant to support a targeted therapy program in oncology, currently in pre-clinical to IND-enabling stages. This role will focus on studies where PK endpoints are critical to advancement, requiring strong expertise in adaptive study design and bioanalytical strategy.

This is a hands-on consulting opportunity suited for a biostatistician who thrives in early development environments and can operate independently while partnering cross-functionally.

 

Key Responsibilities

• Provide statistical leadership for studies designed to generate PK data in support of IND filings
• Lead and advise on adaptive study designs, including dose selection and optimization strategies
• Support and interpret bioanalytical (BA) and bioequivalence (BE) data to inform development decisions
• Contribute to study design, analysis planning, and data interpretation across non-clinical and early-phase development activities
• Collaborate closely with clinical pharmacology, bioanalytical, and development teams to ensure alignment on study objectives and deliverables
• Review and develop statistical input into protocols, analysis plans, and regulatory-facing documentation

 

Required Experience

• Significant experience in biostatistics within drug development, with a strong emphasis on adaptive design methodologies
• Deep expertise in PK-driven studies, particularly those supporting early development and IND-enabling work
• Proven experience with bioanalytical (BA) and bioequivalence (BE) data and study interpretation
• Background supporting oncology programs is preferred, though experience in PK-led development is prioritized
• Prior experience in biotech or pharmaceutical environments
• Ability to work autonomously in a part-time consulting capacity and navigate evolving program needs

 

Program Context

• Focused on targeted oncology therapies with limited public visibility
• Work will support progression toward IND filing rather than ongoing clinical trials
• High-impact role influencing early development strategy and decision-making

 

Engagement Details

• Part-time contract (~20 hours per week)
• Initial term of 12–18 months
• Flexible, remote working arrangement

Overview

We are seeking a Manufacturing Quality Engineer to support ongoing production operations in a fast-paced manufacturing environment. This role is responsible for maintaining product quality after release to production, including managing nonconformances, supporting investigations, and partnering with manufacturing and QC teams to resolve issues on the shop floor.

This is a hands-on, production-facing quality role focused on sustaining quality and ensuring consistency across manufacturing processes.

 

Key Responsibilities

• Investigate and resolve nonconformances (NCMRs), deviations, and production quality issues
• Support customer complaint investigations and drive timely resolution
• Maintain and update work instructions and quality documentation
• Partner with Quality Control (QC) to troubleshoot inspection and measurement issues
• Collaborate with manufacturing teams to ensure product is built and released in the correct condition
• Support root cause analysis and implement corrective actions where needed
• Contribute to continuous improvement of production quality processes

 

Required Qualifications

• Experience as a Quality Engineer in a manufacturing environment
• Hands-on experience supporting production floor activities
• Strong background in:
• Nonconformance management (NCMR)
• Mfg. Quality Investigations
• Root cause Analysis investigation
• Production Quality Support
• FMEA
• Customer / Complaint Quality Investigations 
• Ability to work cross-functionally with manufacturing, QC, and engineering teams

 

Preferred Qualifications

• Experience in regulated industries (medical device strongly preferred)
• Familiarity with GD&T and interpretation of complex engineering drawings
• Experience supporting CMM inspection activities (programming not required)
• Exposure or experience with Gage R&R (GR&R) (nice-to-have, not required)

 

What Makes a Strong Candidate

• Experience working in fast-paced or startup manufacturing environments
• Ability to balance regulatory compliance with practical problem-solving
• Strong communication skills and ability to work through cross-functional challenges
• Comfortable taking ownership of issues and driving them to resolution

 

Additional Notes

• This role is focused on production/sustaining quality, not initial validation or NPI work
• Candidates should be comfortable working onsite and directly on the manufacturing floor
• Opportunity to extend or convert based on performance and business needs

Overview

We are seeking a Manufacturing Process & Controls Engineer to support a fast-paced manufacturing environment by investigating and resolving ERP-related production discrepancies, inventory gaps, and incomplete manufacturing jobs.

This role is highly hands-on and operational in nature, requiring close interaction with manufacturing teams, inventory processes, and production records on the manufacturing floor. The individual will physically trace materials, parts, documentation, and job statuses throughout the facility to reconcile manufacturing activity with ERP system records and ensure accurate job closure.

The ideal candidate will bring experience working in regulated manufacturing environments, strong ERP proficiency, and a practical understanding of inventory control, manufacturing operations, and production workflows.

 

Key Responsibilities

• Investigate open, incomplete, or inconsistent manufacturing jobs within the ERP system (Epicor)
• Physically trace and reconcile product, inventory, documentation, and manufacturing records across production areas
• Identify discrepancies between ERP records and actual manufacturing status on the floor
• Support resolution and closure of manufacturing jobs in alignment with operational and regulatory requirements
• Partner directly with manufacturing, inventory control, quality, and operations teams to identify workflow gaps and process breakdowns
• Analyze recurring operational and ERP-related issues and implement corrective process controls
• Develop standardized procedures and workflows to improve manufacturing traceability and ERP accuracy
• Collaborate with ERP and IT stakeholders on process improvements and system enhancements
• Support continuous improvement initiatives focused on manufacturing execution, inventory accuracy, and operational efficiency

 

Required Qualifications

• Experience working in a manufacturing, production, or inventory control environment
• Hands-on experience with ERP systems (Epicor preferred; SAP, Oracle, or equivalent acceptable)
• Experience reconciling manufacturing records, inventory, work orders, or production documentation
• Strong troubleshooting, investigation, and root cause analysis skills
• Comfortable working extensively on the manufacturing floor in a highly cross-functional environment
• Ability to communicate effectively with manufacturing personnel, operations teams, and technical stakeholders

 

Preferred Qualifications

• Experience in regulated manufacturing environments (medical device, aerospace, pharma, etc.)
• Background in inventory control, manufacturing operations, production coordination, or manufacturing quality
• Experience supporting manufacturing documentation controls and traceability
• Exposure to Lean manufacturing, process improvement, or operational excellence initiatives
• Experience supporting ERP implementations, optimization, or workflow improvements

Position Overview:

Our client is an advanced medical device Contract Manufacturer seeking a Senior Manufacturing Quality Engineer to support the buildout, validation, and production readiness of its metal additive manufacturing systems.

This role will take a lead position in manufacturing quality, equipment qualification, process validation, and manufacturing scale-up, supporting the deployment of next-generation 3D printing manufacturing systems. The ideal candidate will bring deep experience in manufacturing quality and validation and be capable of driving complex initiatives in a fast-paced, high-growth environment.

 

Key Responsibilities:

• Lead Installation Qualification (IQ) activities for new 3D printing systems
• Lead and drive equipment and process validation efforts (IQ/OQ/PQ)
• Own and support new product qualification and NPI process validation
• Interpret and analyze dimensional inspection and metrology data
• Lead or guide Gage R&R (measurement system analysis) activities
• Partner cross-functionally with Manufacturing, Quality, and Engineering teams
• Support development of inspection strategies (CMM, QC integration)
• Drive root cause investigations and resolution of manufacturing issues
• Ensure compliance with medical device quality and regulatory standards

 

Qualifications:

• Medical Device Manufacturing Quality Engineering: 8–10+ years’ experience
• Strong experience leading equipment and process validation (IQ/OQ/PQ)
• Experience with capital manufacturing equipment qualification
• Experience supporting NPI and process validation efforts
• Experience in manufacturing scale-up / production readiness environments
• Strong background in metrology, QC inspection, and Gage R&R
• Ability to lead initiatives and influence cross-functional teams
• Strong technical troubleshooting and problem-solving skills

 

Preferred Qualifications:

• Experience supporting new facility buildouts or production line deployment
• Experience with additive manufacturing / 3D printing
• Exposure to complex manufacturing systems or capital equipment
• Familiarity with CMM and metrology workflows
• Experience in high-growth manufacturing environments