Senior manager, quality assurance gxp Work, Jobs in Bewbush, Wsx (with Salaries)

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —Guildford
- Up to 50% travel
- Microsoft Office
- Bachelor's degree
Quick apply
8d
Senior Account Manager
ERGOS UK —Crawley
- £50,000 - £60,000 a year
- Full-time
- Hybrid work
- Sales
- Analysis skills
- Contracts
- Free parking
- Work from home
Quick apply
Qualified Person (QP) / Senior Quality Assurance Manager
Procter & Gamble —Weybridge
- Full-time
- English
- Communication skills
- Employee stock ownership plan
Senior Block Manager (Residential Block Property Management)
Bawtrys Estate Management Ltd —Sevenoaks
- £48,000 - £55,000 a year
- Full-time
- Hybrid work
- Management
- Customer service
- IT
- Work from home
Quick apply
Centre Manager - Primrose Lodge
UK Addiction Treatment Centres —Guildford
- £45,000 - £50,000 a year
- Full-time
- Microsoft Outlook
- Management
- Microsoft Office
Quick apply
Contracts Manager
Cooke charman —Crawley
- £31,815.40 - £60,803.08 a year
- Full-time
- Project management
- Organisational skills
- Contracts
Quick apply
10d
Head of Enforcement
Hozah —Croydon
- From £50,000 a year
- Full-time
- Hybrid work
- Supervising experience
- In-person
- Work from home
Quick apply
Group Quality Manager
Respirex International Limited —Redhill
- £60,000 - £70,000 a year
- Full-time
- Microsoft Excel
- Management
- Data analysis skills
- Free parking
- Store discount
Quick apply
New Business Senior Manager
BDO —Gatwick Airport
- Full-time
- Business development
Senior Manager, Operational Excellence (PPI)
Thermo Fisher Scientific —Horsham
- Full-time
- Engineering
- Bachelor's degree
- Continuous improvement
7d
Programme Manager
Health Innovation Kent Surrey Sussex (KSS AHSN) —Gatwick Airport
- £54,000 - £57,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Access
- Management
11d
Senior Transformation Manager
Surrey County Council —Reigate
- From £63,823 a year
- No degree
- Communication skills
- Annual leave
- Employee assistance programme
4d
Senior Quality Engineering Manager
McLaren Racing —Woking
- Full-time
- Bachelor's degree
- Continuous improvement
- Leadership
- Life insurance
Quick apply
Senior Business Development Manager (IT Managed Services)
Proxar Ltd —Sevenoaks
- £60,000 - £70,000 a year
- Full-time
- Hybrid work
- Azure
- Sales
- Salesforce
- Free parking
- Annual leave
Quick apply
1d
Senior Project Manager (SEN Schools Commissioning & Development)
Excelcare Holdings —Bromley
- £65,000 - £72,000 a year
- Full-time
- Project management
- Travel
- Organisational skills
- Employee discount
- Referral programme
Quick apply
National Contract Manager
Atlas Workplace Services —Guildford
- £63,000 - £65,000 a year
- Travel
- Contracts
- Leadership
Quick apply
9d
Senior Quality Compliance Specialist
Thermo Fisher Scientific —Horsham
- Full-time
- In-person
- Communication skills
1d
HR Case Manager - Field Based ( Nationwide travel)
Iceland —South Croydon
- Full-time
- Management
- Analysis skills
- Driving
- Store discount
- Employee discount
Senior Environment Advisor
Gatwick Airport Limited —Crawley
- From £46,618 a year
- In-person
- Free parking
8d
Graduate Management Trainee - Crawley / Gatwick / Horsham / Haywards Heath
Enterprise Mobility —Crawley
- Full-time
- Sales
- Customer service
- Bachelor's degree

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Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
Guildford

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Job details

8 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 bewbush, wsx

Senior Manager, Quality Assurance - GxP

Senior Account Manager

Qualified Person (QP) / Senior Quality Assurance Manager

Senior Block Manager (Residential Block Property Management)

Centre Manager - Primrose Lodge

Contracts Manager

Head of Enforcement

Group Quality Manager

New Business Senior Manager

Senior Manager, Operational Excellence (PPI)

Programme Manager

Senior Transformation Manager

Senior Quality Engineering Manager

Senior Business Development Manager (IT Managed Services)

Senior Project Manager (SEN Schools Commissioning & Development)

National Contract Manager

Senior Quality Compliance Specialist

HR Case Manager - Field Based ( Nationwide travel)

Senior Environment Advisor

Graduate Management Trainee - Crawley / Gatwick / Horsham / Haywards Heath

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