Operational Quality Manager
Operational Quality Manager
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Job Description
As Operational Quality Manager (OQM) you are welcomed in a smaller amiable and enthusiastic
QA team where you will have daytoday interaction with other QA experts in the field such as other OQMs Quality Compliance Managers Auditors
As OQM you will be an indispensable partner of the operational teams specifically at our CRO in the management of their part of the quality system. As such you will gain further insight into the CRO activities involved in the conduct of clinical trials for pharma and biotech companies from start to finish.
Your responsibilities:
Your main responsibilities are the following:
- Collaborate with the assigned operational teams at the CRO to improve quality and maintain high quality standards throughout the organization by:
- Developing and maintaining operational quality (SOPs WIs CDs manuals and various guidance documents) and personnel documents
- Supporting the teams by providing additional explanation on topics relating to quality documents/process improvements development of trainings (eLearnings classroom trainings) together with the QA training department
- Initiate process improvements / efficiencies were needed
- Guide the teams through the nonconformance management process by assisting in risk assessment of nonconformances Root Cause Analyses and formulation of CAPA Plans
- Assist the teams in performing their daily work in a consistent and efficient way
- Participate in / facilitate crossfunctional discussions and working groups related to any aspect of quality at the CRO to create or optimize crossfunctional procedures or to look for efficiencies in processes systems and collaboration.
- Support the further development of the new SGS CR electronic Quality Management System.
Qualifications :
- Minimum of 3 years of experience in a CRO or university research (department laboratory) setting or in a pharmaceutical biotech medical devices (or similar) company or equivalent by combination of education training and experience
- A strong affinity with computerized systems and technology in general (including system validation) is considered a significant asset
- Good knowledge of ICHGCP and good documentation practices and experience with project management are a plus
- Fluently writing and speaking English
- Excellent communication and problemsolving skills
- Strong organizational skills
- Proficient in writing
- Good knowledge of MS office
- Assertive and motivated
- Open for discussion and constructive attitude
- Strive for quality and eye for detail
- Stress resistant and flexible
Additional Information :
What we have to offer:
Were you already considering a big switch in your career Maybe this could be your next step. At SGS we can offer you the following:
- An interesting position where you can take responsibility
- An open work atmosphere in an international setting with equal opportunities for all employees
- A dynamic environment that fosters (digital) innovation and inspires employees to drive the business forward proactively and generate success
- Opportunities for personal development by continued education
- Good worklife balance with some possibility of working from home
- Coffee corners and sandwiches in the cafeteria during lunch
- Regular social events (i.e. happy hours)
- A permanent contract with competitive salary package (incl. company car retirement plan meal vouchers )
We are looking for someone who is passionate about quality and ready to work on exciting projects within Clinical Research. If you are looking to advance your career enhance your skills and build connections this position is definitely for you!
Do you want to be part of this
We are looking forward to hearing from you!
Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks. Still have questions Heidi can give you more details about the job. Send her an email at . Please do not apply via mail. Thank you!
Please only apply via the apply button and not via mail.
Please note we cannot support a work permit procedure or relocation.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
