Senior quality assurance manager Work, Jobs in Chineham, Ham (with Salaries)

Senior Manager, Quality Assurance - GxP
PTC Therapeutics International Limited —Guildford
- Up to 50% travel
- Microsoft Office
- Bachelor's degree
Quick apply
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 Programme Manager
QinetiQ —Farnborough
- £75,150 - £83,500 a year
- Full-time
- Employee discount
Regional Operations Support Manager
Aurem Care Shared Services —Reading
- £70,000 a year
- Full-time
- Continuous improvement
- Travel
- Mentoring
- Annual leave
- Employee assistance programme
8d
Centre Manager - Primrose Lodge
UK Addiction Treatment Centres —Guildford
- £45,000 - £50,000 a year
- Full-time
- Microsoft Outlook
- Management
- Microsoft Office
Quick apply
Regional Operations Manager
Cross Rental Services Group —Andover
- HVAC
- Leadership
- Communication skills
Quick apply
Capture Manager
Leidos —Farnborough
- £75,800 - £99,800 a year
- Full-time
- Sales
- Business development
- IT
- Annual leave
- Work from home
Senior Manager, Regional HR Operations, UK & Ireland
ICON Plc —Reading
- Full-time
- Bachelor's degree
- Continuous improvement
- Human resources
- Employee assistance programme
3d
Customer Operational Delivery Manager
Once For All UK —Basingstoke
- £55,000 - £60,000 a year
- Management
- Customer service
- Communication skills
- Employee assistance programme
Quick apply
Finance Business Partner and FP&A Manager
Node4 —Newbury
- Microsoft Excel
- Analysis skills
- IT
- Employee assistance programme
Divisional Business Manager - Education
Salutem Care & Education —Windsor
- £60,000 - £68,000 a year
- Microsoft Excel
- Management
- Data analysis skills
Senior Project Manager - Estates
QinetiQ —Farnborough
- Full-time
- Project management
- Contracts
- Communication skills
- Employee discount
11d
Group Leader Operational Readiness & Transition
AWE —Reading
- £87,000 - £97,000 a year
- Full-time
- Communication skills
- Free parking
- Annual leave
12d
Senior Support Worker
Keys Children —Tadley
- £16.25 - £16.85 an hour
- Weekend availability
- Military
- Care plans
- Communication skills
- Annual leave
Quick apply
Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed
PrimeVigilance —Guildford
- Full-time
- Remote
- Nursing
- English
- Microsoft Office
Quick apply
Senior Healthy Lifestyle Advisor
ICE Creates —Reading
- £28,000 a year
- Weekend availability
- Hybrid work
- Supervising experience
- No degree
- Travel
- Health & wellbeing programme
- Sick pay
Quick apply
1d
Assistant Unit Manager
Hampshire County Council —Alton
- £33,178 - £36,369 a year
- Weekend availability
- Microsoft Outlook
- IT
- Care plans
- Annual leave
- Employee assistance programme
Housing Delivery Senior Project Officer (Capital Projects))
Reading Borough Council —Reading
- £50,269 - £56,730 a year
- Full-time
- Presentation skills
- Communication skills
Associate Quality and Systems Manager – (Asbestos, Fire & Water)
Tetra tech Ltd. —Basingstoke
- Hybrid work
- Travel
- Leadership
Quick apply
11d

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Senior Manager, Quality Assurance - GxP

PTC Therapeutics International Limited -
Guildford

Quick apply

Job details

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 chineham, ham

Senior Manager, Quality Assurance - GxP

Senior Quality Assurance Manager (Clinical)

Senior Product Assurance Manager

Senior Programme Manager

Regional Operations Support Manager

Centre Manager - Primrose Lodge

Regional Operations Manager

Capture Manager

Senior Manager, Regional HR Operations, UK & Ireland

Customer Operational Delivery Manager

Finance Business Partner and FP&A Manager

Divisional Business Manager - Education

Senior Project Manager - Estates

Group Leader Operational Readiness & Transition

Senior Support Worker

Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed

Senior Healthy Lifestyle Advisor

Assistant Unit Manager

Housing Delivery Senior Project Officer (Capital Projects))

Associate Quality and Systems Manager – (Asbestos, Fire & Water)

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