Senior Quality Officer
AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics. Its most advanced asset, known as Ilofotase Alpha (or recAP), is a fully human recombinant form of AP. In 2018, the company successfully completed a Phase IIb trial in sepsis-associated acute kidney injury patients (SA-AKI). The focus has since been on funding and execution of the Phase III / registration trial and preparation for launch. The company is gearing up to build the organization that will deliver on the next phase of evolution.
The new AM-Pharma organization has involved several new key positions with large pharma / biotech Phase III experience. The focus will be on Operational Excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package and to be ready for launch. The bandwidth of the organization will allow for expanding the pipeline and/or accommodating new strategic opportunities. To support the expansion of AM-Pharma’s business, we are currently looking for a
Sr. Quality Officer
About the role
At AM-Pharma, we are actively conducting global Phase III programs treating critically ill patients with acute kidney injury in partnership with a clinical research organization. As Sr. Quality Officer, you support the Sr. Director Quality Management with the design, development and execution of Quality policies and guidelines, the approval of quality documents, review and improvement of the GCP and GMP compliance of the company and with professionalizing the quality systems of the company. You are responsible for
- Reviewing, revising and approving Quality documents through our document change process;
- Reviewing and approving of change requests, deviation reports, complaints and CAPA’s;
- Reviewing and approving of clinical trial reports in case of deviations and complaints;
- Keeping track of change requests, deviations and CAPA’s and closing and archiving of completed documents;
- Reviewing and approving of validation, stability and transfer protocols and reports;
- Conducting audits at vendors, on systems and analytical methods;
- Reviewing and approving of batch documentation, QC results and reports of findings to the QP of AM-Pharma;
- (Co-)executor of audits; executing internal and vendor audits and reporting about the results;
- Setting up systems for mock-recalls and assist in execution;
- Reporting of quality KPI’s and other information for management review purposes;
- Assist with regulatory inspections;
- Designing and improving AM-Pharma’s quality system, including writing new protocols, improving existing protocols and the design and maintenance of databases;
- Providing advice and training to colleagues and peers about GCP, GMP and basic quality systems.
What we expect
We expect our Sr. Quality Officer to keep a Bachelor or Master degree, a completed education in Pharmacy, Bio-pharmaceutical Science, Biochemistry or comparable. The Sr. Quality Officer has
- A minimum of 5 years of experience in a Quality management department in a biopharmaceutical environment;
- Proven knowledge about Quality systems in GMP, and preferably in GCP.
- Understands the dynamics of Clinical Operations including Regulatory and CMC processes and supply chain;
- Ability to work with MS Office software (including Excel, Word, PowerPoint);
- Proficiency in written and spoken English;
- Ability to plan, organize, prioritize and execute multiple tasks within assigned objectives;
- Ability to work effectively in an international matrix team and value the importance of teamwork;
- Ability to deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech;
AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.
Salary at market level, depending on education and working experience
Company pension scheme (100% contribution by employer)
Mobile phone and laptop
Full reimbursement of public transportation or travel allowance of Euro 0,19 per km
As soon as possible
AM-Pharma is currently located in the brand-new World Trade Center Utrecht Central, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport.
How to apply
Please send your CV and cover letter, stating the title of the position you are applying for,
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