QA Program Manager Quality Agreements - L

Employer
CROMSOURCE
Location
Germany
Salary
Competitive
Closing date
24 Sep 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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Description:
Job Title: QA Program Manager, Quality Agreements

Location: Germany - Rhineland Palatinate

Schedule: Full time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting a QA Program Manager, Quality Agreements to strengthen the team of one of our clients.

Our client is a global, research-based BioPharma company dedicated to developing innovative therapies for some of the world's most complex and serious diseases. The company's mission is to significantly improve treatment options in four therapeutic areas: immunology, oncology, virology and neuroscience with its expertise, committed employees and innovative aspirations. In more than 75 countries, employees work every day to advance health care for people around the world.

Main Job Tasks and Responsibilities

  • Primarily responsible for developing, negotiating and writing new and revised quality agreements and supporting
  • agreements for R&D (LC and for LU, Japan and Singapore and Operations (with R&D involvement) as needed).
  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
  • AbbVie R&D Quality Agreement liaison with Operations including negotiating / writing R&D elements for shared R&D / Operations Quality Agreements and associated documents
  • Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
  • Manage processes for the timely QA writing / review / approval of Quality Agreement related policies, processes, procedures, templates and other documentation
  • Identify, lead / facilitate process improvement and efficiency projects pertaining to GxP Compliance within R&D and between R&D and Operations and / or Third Parties
  • Collect, analyze and report metrics pertaining to GxP Compliance
  • Support audit activities with respect to Quality Agreements and other Quality System elements including audit preparation, responding to audit requests, subject matter expert resource
  • Effectively communicate audit results, both orally and in writing. Review corrective action plans / audit responses for adequacy and approve if adequate
  • Review/edit GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidances/industry standards and AbbVie Quality System requirements.
  • Support Dossier Audit Program through the conduct of peer reviews, audit scheduling activities, metrics reporting, represent R&D QA for Dossier Program related meetings/activities/functions.


Education and Experience

  • Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering, or equivalent experience required
  • 3+ years' experience in Quality Assurance or related field
  • 3-5 years' experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred)
  • 3+ years' experience in Clinical Research Development / Manufacturing, finishing or analysis of investigational drug supplies
  • Minimum of 5 years' total combined experience required (Not necessarily the sum of the above)


Skills
  • Excellent communication skills (also in English)
  • Reliability and a high degree of flexibility and resilience
  • Independent and responsible way of working


The Benefits of Working for TalentSource in Germany
  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Full performance and development process with end of year reviews
  • Team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website https://www.talentsourcelifesciences.com

or please contact Alexander.Sourounis@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Quality, Regulatory
Skills: Quality Assurance Specialist Location: Germany Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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