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Quality Operations Manager
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Team management
- Leadership
- Communication skills
IRE_Qualified Person
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Management
- Engineering
- Bachelor's degree
Sr. Validation Specialist
PCI Pharma Services —Stamullin, County Meath
- Full-time
Associate Director, QC Bioassays & Vaccine Potency - Dundalk
MSD —Dundalk, County Louth
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- No degree
7d
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Citco —County Dublin
- Full-time
- Analysis skills
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Team Lead – Electrical Design Substations
TLI Group Ltd —Limerick, County Limerick
- AutoCAD
- Microsoft Office
- No degree
Senior/Principal Water Scientist
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
8d
Project Quantity Surveyor:Buildings
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
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8d
Senior Electrical Engineer – Electrical Design Substations
TLI Group Ltd —Dublin, County Dublin
- AutoCAD
- Microsoft Office
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- Annual leave
- Employee assistance program
cGMP Production Manager
WEP Clinical —Dublin, County Dublin
- Full-time
- ERP systems
- English
2d
Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre
UPMC —Limerick, County Limerick
- €62,077.17–€76,158.63 a year
- Microsoft Powerpoint
- Microsoft Word
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Electrical Maintenance Engineer (Senior Authorised Person)
Centrica Business Solutions —Dublin, County Dublin
- On call
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Mechanical Stress Engineer
Boeing —Dublin, County Dublin
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Clinical Nurse Specialist Radiation Oncology - Limerick Cancer Centre
UPMC —Limerick, County Limerick
- €62,697.94–€79,227.06 a year
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8d
Control & Protection Engineer
NeoDyne —Cork, County Cork
- Overtime
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Quick apply
Principal Engineer - Data Centres (HV Substation Design) - ROI
AECOM —Dublin, County Dublin
- Full-time
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- Up to €18 an hour
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Quality Operations Manager

PCI Pharma Services -
Stamullin, County Meath

Apply Now

Job details

Full-time

Qualifications

Team management
Packaging
Business requirements
Leadership
Communication skills

Full job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Description

Summary of Role

This operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.

Key Responsibilities:

Quality Leadership & Strategy

Lead the development and execution of quality operations, overseeing all batch manufacturing record generation, and review. Responsible for all production related quality assurance
Partner with peer Quality Managers and Quality Systems Manager to drive QA optimization strategies and generate company-wide continuous improvement initiatives
Establish cross-functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability

Process Excellence & Compliance

Own the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality-related forms and records
Authorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction
Ensure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner.

Team Leadership & Development

Provide direction and leadership to the quality operations team (~10 direct reports), establishing performance frameworks and operational excellence standards
Implement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators
Champion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives

Operationaxc

Execute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations
Oversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution
Direct quality operations across incoming goods receipt and related supply chain touchpoints

Customer & Stakeholder Management

Lead high-level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership
Serve as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening
Champion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives.

Subject Matter Expertise

Establish and maintain deep technical expertise in packaging and quality processes, serving as the go-to authority for customer and regulatory audit support
Drive project leadership and cross-functional collaboration to meet evolving business requirements and organizational objectives

Essential

Minimum 10 years’ experience in Quality for a pharmaceutical company operating to EU GMP standards.
2 -5 years’ experience in a leadership or team management role
Broad and deep understanding of EudraLex Vol 4, its key chapters and annex's
Understanding of serialisation requirements.
A flexible and willing attitude
Communication skills to interact with internal and external customers at a senior level.
Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, customers and suppliers
Design and develop new equipment to help improve line effectiveness.
Ability to influence and collaborate at all levels in order to achieve company targets.
Ability to represent the company in a professional and highly competent manner.
Able to multitask and prioritise activities.
Ability to work on their own as well as part of a team.
Excellent problem-solving skills.
Dependable, reliable and robust personal integrity.

Desirable

Experience in a quality operations department, with responsibility for batch release in support of a Qualified Person Function
Experience in hosting regulatory inspections
Detailed understanding of both primary and secondary packaging processes.

#LI-JP1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Apply Now

Refine Your Search

secondary project jobs

Quality Operations Manager

IRE_Qualified Person

Sr. Validation Specialist

Associate Director, QC Bioassays & Vaccine Potency - Dundalk

AVP - Loan Operations

Team Lead – Electrical Design Substations

Senior/Principal Water Scientist

Project Quantity Surveyor:Buildings

Senior Electrical Engineer – Electrical Design Substations

cGMP Production Manager

Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre

Electrical Maintenance Engineer (Senior Authorised Person)

Mechanical Stress Engineer

Clinical Nurse Specialist Radiation Oncology - Limerick Cancer Centre

Control & Protection Engineer

Principal Engineer - Data Centres (HV Substation Design) - ROI

Steel Fabricator/Welder

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