Find Gmp compliance lead Jobs in Dublin, D

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —DUBLIN 2, County Dublin
- Full-time
- Microsoft Office
- Bachelor's degree
- Mentoring
Quick apply
Senior Manager, Supply Chain Finance & Inventory Governance
Gilead Sciences —Dublin, County Dublin
- Full-time
- Oracle
- Inventory control
- ERP systems
Specialist, Safety, Health and Environment
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Weekend availability
- Bachelor's degree
- No degree
- Communication skills
Sr. Automation Engineer - Packaging
Amgen —Dún Laoghaire, County Dublin
- €76,859.55–€103,986.45 a year
- Management
- Computer Science
- Engineering
General Operative Supervisor
Apleona Ireland —Dublin, County Dublin
- €19–€22 an hour
- Nights as needed
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
Quick apply
8d
Production Team Leader
Keelings —Dublin, County Dublin
- Full-time
- Leadership
Quick apply
Electrical Shift Technician
Veolia Energy Services Ireland Limited. —Dublin, County Dublin
- Full-time
- Maintenance
- No degree
- HVAC
Quick apply
Hygiene Team Supervisor – Night Shift
donnelly fresh. Produce —DUBLIN 15, County Dublin
- €35,000–€38,500 a year
- Full-time
- English
- Microsoft Office
- Supervising experience
- Language training provided
- Sick pay
Quick apply
4d
Electrical Day Technician
Veolia Energy Services Ireland Limited. —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Quality Systems & Compliance Manager
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- Engineering
- Project management
- Bachelor's degree
13d
Microbiology and Sterility Assurance Lead
Baxter —Dublin, County Dublin
- Management
- Clinic
- Continuous improvement
- Annual leave
Staff Quality Engineer II
BD —Dublin, County Dublin
- €75,900–€115,725 a year
- Engineering
- Analysis skills
- Project management
10d
Operations Specialist II (API Manufacturing)
Mallinckrodt —Dublin, County Dublin
- €39,500–€59,500 a year
- Full-time
- Continuous improvement
- Communication skills
12d
GMP Team Lead
Sodexo —Clondalkin, County Dublin
- €16.15–€19.18 an hour
- Full-time
- Customer service
- Organisational skills
- In-person
- Free parking
- Employee assistance program
Quick apply
4d
PM2 Manufacturing Manager (Days)
Amgen —Dún Laoghaire, County Dublin
- €78,613.10–€106,358.90 a year
- Engineering
- English
- Bachelor's degree
10d
Sr. Manager Manufacturing Support - Deviations
Amgen —Dún Laoghaire, County Dublin
- €98,617.85–€133,424.15 a year
- Management
- Engineering
- Master's degree
4d
Manufacturing Operations Support Manager
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- Engineering
- Supervising experience
- Bachelor's degree
4d
Senior Specialist, Commercial Stability
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Microsoft Excel
- Microsoft Office
- Presentation skills
7d
GMP SUPERVISOR
Sodexo —DUBLIN 22, County Dublin
- €20.28 an hour
- Full-time
- Organisational skills
- In-person
- Leadership
- Free parking
- Employee assistance program
Quick apply
11d
Senior Specialist, Commercial Stability
AstraZeneca —Dublin, County Dublin
- Microsoft Excel
- Microsoft Office
- Presentation skills
7d

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Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
DUBLIN 2, County Dublin

Quick apply

Job details

Full-time

Qualifications

Microsoft Office
Quality assurance
Bachelor's degree
Mentoring
Leadership
Communication skills
Time management

Full job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Senior Manager, Quality Assurance - GxP is responsible for conducting audits with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for PTC commercial and clinical activities in both the small molecule and large molecule space.
This involves engaging and collaborating with cross functional internal teams to evaluate CMC processes, procedures, and activities for adherence to relevant industry standards, regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
She/He may manage direct reports.

Job Description:

Responsibilities for the role include:

The incumbent works cross-functionally with internal departments and external resources on GxP QA related issues.

The Senior Manager, Quality Assurance – GxP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.

Contributes to and executes PTC’s GxP risk-based audit strategy to achieve compliance with applicable current regulatory requirements.
Performs internal and external audits as assigned to ensure compliance with GMP and GDP regulations (may include internal processes, Contract Manufacturing Organizations (CMOs), laboratories distributors, and other vendors).
- Communicates audit results to stakeholders and writes audit report.
- Assesses audit responses and ensures closure of corrective and preventative actions (CAPAs).
Leads backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.

Supports Quality Management System (QMS) including, but not be limited to, the following activities:
QA review/approval of deviations, CAPAs and change controls.
Drafts, reviews, and approves SOPs.
May manage, coach, and mentor direct reports.
Performs other tasks and assignments as needed and specified by management

Requirements for the role include:

Bachelor’s degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance, Regulatory Affairs, Manufacturing, or a related role in a pharmaceutical, biotechnology or related environment.
Demonstrated ability to work as a team player: listens, promote exchanges, communicates, adapts and advises.

Detailed knowledge and understanding of GMP regulations.
Demonstrated experience leading and/or conducting audits.
Demonstrated experience executing risk-based audit plans.
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
Experience supporting regulatory agency inspections.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Knowledge and experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP).
Registered GxP Quality Assurance Certifications.

Travel requirements 50%

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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gmp compliance lead jobs in dublin, d

Senior Manager, Quality Assurance - GxP

Senior Manager, Supply Chain Finance & Inventory Governance

Specialist, Safety, Health and Environment

Sr. Automation Engineer - Packaging

General Operative Supervisor

Production Team Leader

Electrical Shift Technician

Hygiene Team Supervisor – Night Shift

Electrical Day Technician

Quality Systems & Compliance Manager

Microbiology and Sterility Assurance Lead

Staff Quality Engineer II

Operations Specialist II (API Manufacturing)

GMP Team Lead

PM2 Manufacturing Manager (Days)

Sr. Manager Manufacturing Support - Deviations

Manufacturing Operations Support Manager

Senior Specialist, Commercial Stability

GMP SUPERVISOR

Senior Specialist, Commercial Stability

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