Quality and regulatory affairs manager 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
Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed
PrimeVigilance —Guildford
- Full-time
- Remote
- Nursing
- English
- Microsoft Office
Quick apply
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience
6h
QA Manager - New Product Introduction
GE HEALTHCARE —Chalfont Saint Giles
- Bachelor's degree
- Continuous improvement
- Travel
11d
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Management
- Research
- Recruiting
10d
Senior Commercial Officer - Infrastructure North & South
Department for Environment, Food and Rural Affairs —Reading
- £42,665 - £46,765 a year
- Part-time
- Presentation skills
- Leadership
10d
PV Officer, Team Lead (Japanese Fluency required )
PrimeVigilance —Guildford
- Full-time
- Remote
- Nursing
- English
- Communication skills
Quick apply
Operations Manager
Veterinary Medicines Directorate —New Haw
- £38,795 a year
- Part-time
- Microsoft Outlook
- Databases
- Analysis skills
- Free parking
- Annual leave
7d
Solutions Consultant- UK/Europe
MasterControl —Basingstoke
- Microsoft Office
- Presentation skills
- Bachelor's degree
- Annual leave
- Life insurance
Water & Waste Stewardship Manager
Reckitt —Slough
- Remote
- Engineering
- Analysis skills
- Travel
- Employee assistance programme
- Life insurance
Commercial Manager
Archit Pharma Innovations Ltd —Cox Green
- £34,000 - £36,000 a year
- Full-time
- CRM software
- Microsoft Office
- Business development
Quick apply
13d
Enterprise Account Executive (Europe)
MasterControl —Basingstoke
- English
- Travel
- Computer skills

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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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quality and regulatory affairs manager jobs in reading, eng

Senior Manager, Quality Assurance - GxP

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

Local Study Associate Director

Medical Affairs Coordinator

QA Manager - New Product Introduction

Country Medical Director, UK and Ireland

Senior Commercial Officer - Infrastructure North & South

PV Officer, Team Lead (Japanese Fluency required )

Operations Manager

Solutions Consultant- UK/Europe

Water & Waste Stewardship Manager

Commercial Manager

Enterprise Account Executive (Europe)

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