Senior manager, quality assurance gxp Work, Jobs in Reading, Eng (with Salaries)

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —Guildford
- Up to 50% travel
- Microsoft Office
- Bachelor's degree
Quick apply
2d
Peripatetic Senior Home Manager
Aurem Care Shared Services —Reading
- £70,000 a year
- Full-time
- Continuous improvement
- Travel
- Mentoring
- Annual leave
- Employee assistance programme
1d
Senior Product Assurance Manager
Astroscale —Didcot
- £60,000 - £94,000 a year
- Full-time
- Hybrid work
- English
- Presentation skills
- Travel
- Life insurance
- Sick pay
10d
Senior Projects Manager Disrepair & Damp & Mould
A2Dominion Group —Staines-upon-Thames
- £69,922 - £84,642 a year
- Data analysis skills
- English
- Contracts
- Employee discount
Senior Program Manager
ASSA ABLOY —Reading
- Part-time
- Spanish
- Computer Science
- PMP
- Annual leave
Senior Contract Manager
AWE —Reading
- £63,000 - £75,000 a year
- Full-time
- Hybrid work
- Management
- Travel
- Contracts
- Free parking
- Annual leave
Senior Logistics Operations Manager
PTS Solid Logistics Ltd —Reading
- £52,000 - £65,000 a year
- Full-time
- Customer service
- Microsoft Office
- Bachelor's degree
- Life insurance
- Sick pay
Quick apply
3d
Qualified Person (QP) / Senior Quality Assurance Manager
Procter & Gamble —Weybridge
- Full-time
- English
- Communication skills
- Employee stock ownership plan
Senior Quality Assurance Manager (Clinical)
Bio Pharma Resourcing —Thames Valley
- £35,000 - £40,000 a year
- Travel
- Computer skills
Senior Customer Experience Manager
Novuna —Newbury
- £60,000 a year
- Full-time
- Hybrid work
- Team management
9d
Senior Quality Engineering Manager
McLaren Racing —Woking
- Full-time
- Bachelor's degree
- Continuous improvement
- Leadership
- Life insurance
Quick apply
Senior Category Manager
AWE —Reading
- £63,270 - £85,000 a year
- Full-time
- Hybrid work
- Free parking
- Annual leave
Global Senior Mid-Level Giving Manager
Compassion in World Farming —Godalming
- £47,000 - £500,000 a year
- Full-time
- Hybrid work
- Driving
- Communication skills
- Free parking
- Annual leave
Audit Quality - Corporate Reporting Advisory Senior Manager
BDO —Reading
- Full-time
- Accounting
- Communication skills
Senior Healthcare Global Product Manager Ostomy
Hollister Europe Limited —Winnersh
- £51,282 - £80,585 a year
- Microsoft Powerpoint
- Marketing
- English
- Annual leave
- Employee assistance programme
Transaction Services Manager/Senior Manager
BDO —Reading
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Management
Senior Programme Manager
University of Oxford —Oxford
- £56,623 - £66,336 a year
- Full-time
- Analysis skills
- University
- No degree
- Annual leave
5d
QA Senior Manager
Fortrea —Maidenhead
- Full-time
- Bachelor's degree
- Leadership
- Negotiation
Senior Technical Project Manager – Data Centres & Enterprise Infrastructure
Protek Systems Limited —Oxford
- £70,000 - £80,000 a year
- Full-time
- Hybrid work
- Travel
- Organisational skills
- Leadership
Quick apply
4d
Compliance Manager
Reading Blue Coat School —Reading
- £50,000 a year
- Part-time
- Project management
- Bachelor's degree
- IT
- Free parking
- Employee assistance programme
Quick apply

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senior manager, quality assurance gxp jobs near reading, eng

Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
Guildford

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Job details

2 days ago

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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senior manager, quality assurance gxp jobs in reading, eng

Senior Manager, Quality Assurance - GxP

Peripatetic Senior Home Manager

Senior Product Assurance Manager

Senior Projects Manager Disrepair & Damp & Mould

Senior Program Manager

Senior Contract Manager

Senior Logistics Operations Manager

Qualified Person (QP) / Senior Quality Assurance Manager

Senior Quality Assurance Manager (Clinical)

Senior Customer Experience Manager

Senior Quality Engineering Manager

Senior Category Manager

Global Senior Mid-Level Giving Manager

Audit Quality - Corporate Reporting Advisory Senior Manager

Senior Healthcare Global Product Manager Ostomy

Transaction Services Manager/Senior Manager

Senior Programme Manager

QA Senior Manager

Senior Technical Project Manager – Data Centres & Enterprise Infrastructure

Compliance Manager

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