Senior quality assurance manager Work, Jobs in Stratfield Mortimer, Brk (with Salaries)

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —Guildford
- Up to 50% travel
- Microsoft Office
- Bachelor's degree
Quick apply
10d
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 Product Assurance Manager
Astroscale —Didcot
- £60,000 - £94,000 a year
- Full-time
- Hybrid work
- English
- Presentation skills
- Travel
- Life insurance
- Sick pay
Senior Project Delivery Manager
Aster Group —Andover
- £70,593 a year
- Full-time
- Hybrid work
- Continuous improvement
- No degree
- Construction experience
- Employee assistance programme
Regional Operations Support Manager
Aurem Care Shared Services —Reading
- £70,000 a year
- Full-time
- Continuous improvement
- Travel
- Mentoring
- Annual leave
- Employee assistance programme
3d
Associate Director Quality - Client Dedicated ( Regional Clinical Compliance Lead)
IQVIA —Reading
- Full-time
- Remote
- Management
- English
- Microsoft Office
- Work from home
5d
Senior Programme Manager
QinetiQ —Farnborough
- £75,150 - £83,500 a year
- Full-time
- Employee discount
Centre Manager - Primrose Lodge
UK Addiction Treatment Centres —Guildford
- £45,000 - £50,000 a year
- Full-time
- Microsoft Outlook
- Management
- Microsoft Office
Quick apply
Capture Manager
Leidos —Farnborough
- £75,800 - £99,800 a year
- Full-time
- Sales
- Business development
- IT
- Annual leave
- Work from home
Group Leader Operational Readiness & Transition
AWE —Reading
- £87,000 - £97,000 a year
- Full-time
- Communication skills
- Free parking
- Annual leave
7d
Senior Quality Engineering Manager
McLaren Racing —Woking
- Full-time
- Bachelor's degree
- Continuous improvement
- Leadership
- Life insurance
Quick apply
Supported Living Manager
Thrive Together Care —Earley
- £40,000 - £44,000 a year
- Full-time
- Management
- Mentoring
- Organisational skills
Quick apply
7d
Housing Delivery Senior Project Officer (Capital Projects))
Reading Borough Council —Reading
- £50,269 - £56,730 a year
- Full-time
- Presentation skills
- Communication skills
13d
Health & Safety Business Partner
Impact Food Group —Reading
- Full-time
- Presentation skills
- Travel
- Communication skills
- Annual leave
- Employee discount
Quick apply
Senior Project Manager H/F
Groupe Ortec —Theale
- £75,000 - £82,000 a year
- Management
- Engineering
- Project management
- Employee assistance programme
Quick apply
Senior Pensions Administrator (Insurance)
XPS Pensions Group —Reading
- Full-time
- Hybrid work
- Computer literacy
- Microsoft Office
- Employee discount
- Referral programme
Finance Business Partner and FP&A Manager
Node4 —Newbury
- Microsoft Excel
- Analysis skills
- IT
- Employee assistance programme
14d
QA Senior Manager
Fortrea —Maidenhead
- Full-time
- Bachelor's degree
- Leadership
- Negotiation
Pensions Administration Manager (Insurance)
XPS Pensions Group —Reading
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee discount
- Referral programme

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Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
Guildford

Quick apply

Job details

10 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 quality assurance manager jobs in stratfield mortimer, brk

Senior Manager, Quality Assurance - GxP

Qualified Person (QP) / Senior Quality Assurance Manager

Senior Quality Assurance Manager (Clinical)

Senior Product Assurance Manager

Senior Project Delivery Manager

Regional Operations Support Manager

Associate Director Quality - Client Dedicated ( Regional Clinical Compliance Lead)

Senior Programme Manager

Centre Manager - Primrose Lodge

Capture Manager

Group Leader Operational Readiness & Transition

Senior Quality Engineering Manager

Supported Living Manager

Housing Delivery Senior Project Officer (Capital Projects))

Health & Safety Business Partner

Senior Project Manager H/F

Senior Pensions Administrator (Insurance)

Finance Business Partner and FP&A Manager

QA Senior Manager

Pensions Administration Manager (Insurance)

I want to receive the latest job alerts for senior quality assurance manager in stratfield mortimer, brk

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