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QA Manager - Client-dedicated

Pharmaceutical Product Development (PPD)

Multiple Locations

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

To further strengthen our Quality team (dedicated to one client only), we are looking for a motivated R&D Lab Manager with a quality mindset. You will use client SOPs and clinical systems.

Key Accountabilities and Responsibilities:

The role is responsible for performing duties related to quality review of R&D plans and reports, working in close collaboration with the R&D teams (Discovery) and GLP Quality Manager:

Review of experiments in electronic Lab Notebook

Review of study plans and reports

Administrative support keeping track of study plans and reports

Qualification of vendors (non-GxP), including animal welfare check

Ensure availability of Human Body Material (HBM) samples for R&D purposes i.e. qualification of HBM suppliers, maintenance of biobank, communication with blood banks

Ensure Quality goals are met and all practices and procedures comply with company policies and applicable regulations

Support the further build-out of quality processes and systems within R&D

The role may also support the QA team with additional ad hoc project support.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

To further strengthen our Quality team (dedicated to one client only), we are looking for a motivated R&D Lab Manager with a quality mindset. You will use client SOPs and clinical systems.

Key Accountabilities and Responsibilities:

The role is responsible for performing duties related to quality review of R&D plans and reports, working in close collaboration with the R&D teams (Discovery) and GLP Quality Manager:

Review of experiments in electronic Lab Notebook

Review of study plans and reports

Administrative support keeping track of study plans and reports

Qualification of vendors (non-GxP), including animal welfare check

Ensure availability of Human Body Material (HBM) samples for R&D purposes i.e. qualification of HBM suppliers, maintenance of biobank, communication with blood banks

Ensure Quality goals are met and all practices and procedures comply with company policies and applicable regulations

Support the further build-out of quality processes and systems within R&D

The role may also support the QA team with additional ad hoc project support.

Desired Skills and Experiences:3y experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological analytical methods.Experience with lab activities is a plus.Experience with audits is a plusQuality attitude; can do mentality;Good organization and planning skills;Strong communication skills and able to build relationship with business partners and to work effectively together with others;Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.Fluent in EnglishWhat we offer:

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1

Desired Skills and Experiences:3y experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological analytical methods.Experience with lab activities is a plus.Experience with audits is a plusQuality attitude; can do mentality;Good organization and planning skills;Strong communication skills and able to build relationship with business partners and to work effectively together with others;Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.Fluent in EnglishWhat we offer:

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1

Job posted: 2020-11-25

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