Find Senior manager, global device Jobs in Balbriggan, D

Associate Director Validation
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Head of Marketing with Ukranian/Russian
RadioKing —DUBLIN 11, County Dublin
- €30,000–€50,000 a year
- Full-time
- Social media management
- Analysis skills
- Project management
- Profit sharing
- Employee discount
Quick apply
2h
Junior Operations Manager
The Fruit People —DUBLIN 11, County Dublin
- €50,000–€55,000 a year
- Full-time
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Communications & Administration Officer
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Assistant Director of Nursing (ADON)
St Michaels House —Ballymun, County Dublin
- €72,843–€89,894 a year
- Full-time
- English
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Senior HR Administrator
Keelings —Saint Margaret's, County Dublin
- Full-time
- English
- Microsoft Office
- Human resources
Quick apply
5h
Contracts Manager | Swords
Glanua —Swords, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
- Employee assistance program
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5h
Corporate Governance & Finance Compliance Specialist (EMEA Supply)
Decathlon UK —DUBLIN 11, County Dublin
- €45,000 a year
- Bachelor's degree
- In-person
- Business
- Free parking
- Profit sharing
6d
Senior Speech and Language Therapist in Paediatric Cochlear Implant
Beaumont Hospital —Dublin, County Dublin
- Full-time
6d
MEP Agent / Mechanical & Electrical Site Agent
Wills Bros Limited —Dublin Airport, County Dublin
- Full-time
- AutoCAD
- English
- Project management
- Annual leave
- Employee assistance program
Quick apply
7d
Assistant Manager, GRA Business Process
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- No degree
- SharePoint
7d
Psychologist Senior Síceolaí Sinsearach DNE26126
Health Service Executive —North Dublin, County Dublin
7d
Junior Installer
Wayfinders —Baldoyle, County Dublin
- Full-time
- No degree
- Construction experience
- In-person
Quick apply
8d
Environmental, Health & Safety Advisor
Flynn —DUBLIN 11, County Dublin
- Full-time
- Communication skills
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9d
Graduate Engineer - Drogheda
EPS Group —Drogheda, County Louth
- Full-time
- AutoCAD
- Engineering
- Bachelor's degree
Quick apply
9d
Delivery & Installation Driver 7.5T
The Sofa Delivery Company —Swords, County Dublin
- €20.81 an hour
- Driving
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- Annual leave
Quick apply
10d
Delivery & Installation Driver 3.5T
The Sofa Delivery Company —Swords, County Dublin
- €16.16 an hour
- No experience needed
- Annual leave
Quick apply
10d
Senior Private Client Tax Advisor
Coventure Tax Consulting —DUBLIN 17, County Dublin
- €60,000–€85,000 a year
- Full-time
- Accounting
- Leadership
- Accounting
Quick apply
10d
Project Quantity Surveyor
Flynn —DUBLIN 11, County Dublin
- Full-time
- Bachelor's degree
- Conflict management
- Negotiation
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10d
Head of Legal
Flynn —DUBLIN 11, County Dublin
- Full-time
- Continuous improvement
- Team management
- Conflict management
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10d

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Associate Director Validation

PCI Pharma Services -
Stamullin, County Meath

Apply Now

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Office
Bachelor's degree
Business requirements
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.

This role will be a key member of the Site Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Validation Team, Quality, and function departments validation work closely with.

The role of the Associate Director Validation is to lead the implementation and execution tasks relating to Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning and Equipment Development at PCI Ireland Pharma Services sites.

Main responsibilities:

The Associate Director Validation is responsible for PCI Ireland validation design, strategy, compliance, and overall adherence to VMP.
The Associate Director Validation is responsible for communicating the strategy to site leadership and working closely with all functional departments to ensure the VMP is understood and ultimately adhered to.
Ensuring all validation activities on site relating to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
Define Validation KPI’s, and validation schedule. Utilise SQDC to manage operations for validation and provide weekly summary of SQDC outputs to Quality Director.
Manage the validation team. Train, develop, coach the team on the validation system, documenting, and execution. Manage HR related activities. Complete Quantum for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations.
The Associate Director of Validation is a key member of the site leadership team. In that capacity the incumbent must flag concerns with site validation should any be found, work with other departments (Engineering, Production, NPI, QC and others) to ensure the validation needs are understood. Validation depart must utilise risk methodology, be pragmatic, solution orientated with overall focus on validation compliance across the sites.
Be a member of Corporate Centre of Excellence (COE) ensuring best practices are shared and implemented. Work closely with sister sites to ensure One PCI experience is demonstrated to our customers.
Ensure periodic review and annual validation plan is in place and adhered to. Any slippages should be reported through SQDC model. Introduce Continuous Process Verification in line with best practice.
Generate validation template protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Protocols should be designed around maximising equipment CSV capability ALCOA+ principles. Ensure all protocols have a clear author and approval process, and its clearly understood within the protocol who is responsible for which activities and it is very clear who executed within the protocol.
Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland in line with current best industry practice.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Manage tooling validations and associated documentation.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Support complaint investigations, deviation investigations and change controls as required.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
Identify and support opportunities for improving processes and or procedures.
Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the validation system.

Essential Requirements:

Bachelor’s or associate degree in Validation / Technical Engineering or Science based subject
+10 years' experience working in Validation across Qualifications and Process Validation
Communication: Excellent communication and presentations skills, both written and oral – ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to Senior Management
QMS system experience necessary
Proven track record of showing how results were delivered through project management
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
Ability to manage multiple tasks and set priorities.
Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
Self-motivated with a results driven approach.
Adaptable and ability to work collaboratively.
Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
Some travel required for business requirements
Customer facing experience
Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles
Decision Making: Identify and understand issues, problems and opportunities whilst providing
Strong insight into Pharma/Medical Device guidelines relating to regulatory and quality requirements

#LI-MS1

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

senior manager, global device jobs in balbriggan, d

Associate Director Validation

Head of Marketing with Ukranian/Russian

Junior Operations Manager

Communications & Administration Officer

Assistant Director of Nursing (ADON)

Senior HR Administrator

Contracts Manager | Swords

Corporate Governance & Finance Compliance Specialist (EMEA Supply)

Senior Speech and Language Therapist in Paediatric Cochlear Implant

MEP Agent / Mechanical & Electrical Site Agent

Assistant Manager, GRA Business Process

Psychologist Senior Síceolaí Sinsearach DNE26126

Junior Installer

Environmental, Health & Safety Advisor

Graduate Engineer - Drogheda

Delivery & Installation Driver 7.5T

Delivery & Installation Driver 3.5T

Senior Private Client Tax Advisor

Project Quantity Surveyor

Head of Legal

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