Senior manager, quality assurance gxp Work, Jobs in Crawley Rh10 (with Salaries)

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —Guildford
- Up to 50% travel
- Bachelor's degree
- Team management
Quick apply
Commercial Manager
OCS Group —Crawley
- Remote
- Microsoft Excel
- Analysis skills
- Contracts
Quick apply
Senior General Foreman/ Works Manager
Jackson Civil Engineering —Haywards Heath
- Full-time
- Civil engineering
- Management
- Construction experience
- Free parking
- Health & wellbeing programme
Quick apply
13d
Senior Bookkeeper / Group Accounts Manager.
Redcoat Express Ltd —Crawley
- £38,371.25 - £46,315.03 a year
- Full-time
- Microsoft Excel
- In-person
- Free parking
Quick apply
13d
Senior Planner
Gatwick Airport Limited —Gatwick Airport
- £78,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Office
- Analysis skills
- Free parking
- Employee discount
5d
Senior Strategic Accounts Manager EMEA
Siemens Healthineers —Crawley
- Hybrid work
- CRM software
- Engineering
- English
Quick apply
19h
Senior Quality Compliance Specialist
Thermo Fisher Scientific —Horsham
- Full-time
- Continuous improvement
- In-person
- Communication skills
Senior HR Business Partner
Air Partner —Gatwick Airport
- £55,000 - £65,000 a year
- Microsoft Powerpoint
- Microsoft Word
- Analysis skills
- Annual leave
- Employee assistance programme
Senior Project Manager
RSPCA —Horsham
- Full-time
- Hybrid work
- Leadership
Senior Design Manager
Kier Group —Woking
- Full-time
- Project management
- Continuous improvement
7d
Construction Operations manager
Joshua Lewis Carpentry & Construction —Reigate
- £55,000 - £65,000 a year
- Full-time
- Continuous improvement
- Team management
- Organisational skills
- Free parking
Quick apply
11d
Senior Manager, Delivery Management
American Express —Burgess Hill
- Full-time
- Computer Science
- Engineering
- Bachelor's degree
- Life insurance
14d
Portfolio Quality Assurance Manager
Thales —Crawley
- Full-time
- Hybrid work
- Continuous improvement
- Annual leave
- Employee assistance programme
Senior Manager UK P&C Services
bp —Sunbury
- Full-time
- Hybrid work
- Management
- Customer service
- No degree
- Relocation assistance
- Annual leave
11d
Senior Project Manager
Balfour Beatty —Lewes
- Hybrid work
- Civil engineering
- Business development
- Continuous improvement
- Annual leave
15h
Senior Communications Manager
Vinarchy —Weybridge
- Employee assistance programme
- Employee discount
Senior Proposition Manager
LegalAndGeneral —Brighton and Hove
- Full-time
- Employee discount
Quick apply
Senior Pharmacovigilance Project Manager- Europe
PrimeVigilance —Guildford
- Full-time
- Remote
- Leadership
Quick apply
7d
Senior Facilities Manager
Balfour Beatty —Brighton
- Hybrid work
- Continuous improvement
- No degree
- Leadership
- Annual leave
Senior Manager, Operational Excellence (PPI)
Thermo Fisher Scientific —Horsham
- Full-time
- Engineering
- Bachelor's degree
- Continuous improvement

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Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
Guildford

Quick apply

Job details

Qualifications

GLP
Stakeholder collaboration
Quality management change control procedures
Stakeholder liaison
Internal quality management system auditing
Compliance audits
Internal department liaison
Microsoft Office Suite
Quality assurance
Bachelor's degree
Team management
Multidisciplinary collaboration
Good Clinical Practice (GCP)
Pharmaceutical industry setting experience
Leadership
EU Good Distribution Practice (GDP)
Communication skills
Internal quality assurance
Good Clinical Practice (ICH-GCP) guidelines
Corporate regulatory compliance oversight
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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senior manager, quality assurance gxp jobs in crawley rh10

Senior Manager, Quality Assurance - GxP

Commercial Manager

Senior General Foreman/ Works Manager

Senior Bookkeeper / Group Accounts Manager.

Senior Planner

Senior Strategic Accounts Manager EMEA

Senior Quality Compliance Specialist

Senior HR Business Partner

Senior Project Manager

Senior Design Manager

Construction Operations manager

Senior Manager, Delivery Management

Portfolio Quality Assurance Manager

Senior Manager UK P&C Services

Senior Project Manager

Senior Communications Manager

Senior Proposition Manager

Senior Pharmacovigilance Project Manager- Europe

Senior Facilities Manager

Senior Manager, Operational Excellence (PPI)

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