Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 13,500+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are a mentor and leader- because being a report pusher isn’t your style!
You like to stay hands on with your audits- (our Managers up the VP still audit!)
You are a strategic thinker with a great attention to detail. – nothing gets past you!
You like variety. – The same old tasks day to day just don’t get you up in the morning!
You have experience with a full range of audits and GxP services.
You believe in consistently delivering quality with each audit you perform.
You have experience traveling (and enjoy being on the road!) to conduct onsite audits.
At the end of the day, you want to work for a company that values your education, knowledge and experience…
a company that is ultimately better with you on their team.
That company is PRA.
Long story short, you will be the QA lead for our clinic in Lenexa; still staying hands on so you can coach and mentor! You will work closely with internal PRA groups to assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting audits of the ongoing inpatient clinical trials, internal process audits, and a variety of other types (such as vendor audits) to support the ongoing assessment and compliance of our research unit.
Still interested? Great, there’s more…
• Organizing and managing the department activities to ensure an optimal realization of corporate policies.
o Provides direction, guidance and leadership.
o Reviews information and results.
o Intervenes when problems arise.
• Stay informed and maintaining a respected status within discipline.
o Stays informed of developments in the field of quality, compliance, quality assurnace, by reading professional literature, participating in symposia etc.
o Participates in meetings and meetings of quality and compliance associations.
o Participates in giving external and internal quality training
• Continuous improvement of the quality of the products within CRO.
o Initiates and participates in working groups and project teams regarding quality improvement programs.
o Advises in case of quality problems (troubleshooting).
o Provides information to employees about inspections, audits, procedures (SOPs), regulations etc.
What do you need to have?
• 5+ years of experience in early or late phase clinical research OR a GCP regulated environment
• 4+ years experience quality management or quality assurance experience in GxP environment
• Phase 1 auditing experience required
• Strong knowledge of GxP’s (GLP, GMP, GCP)
• Read, write and speak fluent English; fluent in host country language required.
• Bachelor’s degree or equivalent in life sciences or related field
• Additional advanced or related degree preferred
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities