QA Manager, Minerva Imaging
Minerva Imaging, Oelstykke, Denmark
Minerva Imaging is a fast growing, entrepreneurial and scientifically driven CRO with the ambition to be the globally leading CRO in our area of expertise. To facilitate the continued strong growth of the company and maintain our position as a top quality provider for global and local life science companies, we seek a QA Manager with the ambition to lead our efforts in quality management.
You will lead and direct quality efforts in the organization in close collaboration with the management team in the company. You will be responsible for the GMP/GLP QMS system and the further development of the system, in close collaboration with key colleagues. Quality is a priority in the organization and You will refer directly to the CEO in the company.
You will work in a science driven environment with the ambition to make a real difference advancing new treatment modalities to patients.
The ideal candidate has a Master of Science in Pharmacy or similar qualifications acquired through your career, relevant for running a GLP and GMP compliant operation.
Besides developing the QMS, we expect the QA to handle the many and varying day-to-day tasks, such as
- Plan, conduct and follow up on GLP/GMP audits according to the audit program and regulatory requirements
- Provide training and expert knowledge on GLP and GMP matters and ensure appropriate training and training records of employees across functions
- Prepare and lead the Minerva team during external inspections by authorities and clients
- Assure all relevant approvals and certificates are in place
- Secure compliance with applicable instructions and regulations, such as the GLP- and GMP requirements
- Review and approve deviations and standard operating procedures, instructions etc.
- Review study protocols and reports and secure consistency in data presentation by implementing/updating our templates
- You should master both Danish and English on a professional level as you will be involved in updating existing Danish SOPs and instructions to English
To succeed in the position, you should have
- Significant experience in GMP and GLP quality management from a QA position and have experience from hosting authority and big pharma audits, ensuring compliance to EU and US GMP and GLP regulations
- Master of Science in Pharmacy or similar qualifications
- Experience as QA responsible for a GMP QMS system (small or large organization)
- Strong IT skills and insight into new digital opportunities
- Strong drive to encourage a quality mindset in the organization and with an understanding of the advantages of quality based data, made correctly in the first attempt
QA experience with radio pharmacy manufacturing under GMP regulations will be an advantage.
On a personal note you are
- Informal, with the authority to drive changes in the organization in a collaborative manner
- Hands-on, problem solving, get-things-done attitude, always with a quality mindset
- A proactive communicator and team-player
- Enthusiastic and passionate, but keeps attention to detail
- Ability to thrive in a fast paced, dynamic, service organization where our clients rely on our ability to run the extra mile
- Fluent in written and oral English
We are an informal organization that values humor, takes natural care for one another and keep an open and honest communication. We offer a challenging and rewarding job in a professional and dedicated environment. At Minerva, we value our employees as important and critical to our success and we are committed to maintain a great and competitive workplace with benefits and development opportunities.
Sounds as you, then please apply no later than March 5th, 2021 to the position by sending your motivated cover letter, CV and relevant certificates to firstname.lastname@example.org. If you have questions to the position, please contact Jacob Jacobsen, member of the board, by e-mail email@example.com or phone +45 27105565. Interviews will be held continuously.
About Minerva Imaging
Minerva Imaging is a scientifically driven CRO founded in 2011 and with 40 employees. Our focus is on the use of advanced oncology models and molecular imaging for translational cancer research and drug development. We engage with our clients to understand their scientific questions and discuss how our methods and capabilities can provide answers. We are growing rapidly and our services are in great demand, and the right candidate will be the key contributor to build GLP and GMP compliance in the organization. You will join a fast paced and highly specialized CRO, with big dreams of taking disease treatment to the next level of personalized medicines.