Blog reader Maria Mantziri reached out to us and volunteered to collaborate on this post. She generously shares her unique perspective and career advice for pharmacists in pharma or those interested in pharmaceutical quality. We are so pleased to highlight her insights, as there are many pharmacists who work in pharma. If you'd like to share your story, please contact us.
1. What is your current position/role, and what are your responsibilities?
I am currently a Quality Project Manager in the German affiliate of a leading biopharmaceutical company, based in Frankfurt. My team works in close collaboration with the Austrian and Swiss affiliates of the company. We focus on the final steps of bringing new products to the market and then post-authorization surveillance and compliance activities.
My main task is to support the maintenance and continuous improvement of the quality system. The pharmaceutical quality system is a set of procedures and structures that assure consistent product quality. This is achieved through monitoring the compliance to controls and quality standards. In addition, the data collected in the framework of the quality system are utilized to produce meaningful performance indicators to identify opportunities for improvement and optimization of the drug development, manufacturing and commercialization processes. In other words, it is a living organism that keeps changing, expanding and adjusting.
I am in the Medical, Clinical and Commercial Quality department. Here, the emphasis of my activities is in the areas of regulatory affairs, pharmacovigilance, clinical studies unit and medical departments. My work includes the documentation of deviations, corrective and preventive actions, change management, risk mitigation and monitoring of our commissioned service providers in the country. Because we outsource several activities to service providers (e.g., research organizations or contract manufacturers), we are responsible for the auditing and qualification of these third parties. Finally, the best part of my current position is my involvement in the launch of new products targeting rare diseases. In this work, I support the project teams in the quality procedures mentioned.
2. Can you describe your education or training and how it prepared you for your current role?
I have a pharmacy degree from the University of Athens in Greece. I believe our curriculum provides a solid basis to enter the job market, mainly in terms of providing a multidisciplinary theoretical background and shaping the way we absorb and process knowledge and scientific information. However, a drawback would be that the first real contact with our profession comes in our final internship year. Even then, in my case, the available opportunities were significantly limited in Greece.
When new pharmacists start in junior positions, they are not expected to be able to master the specific needs of the position from day one. Training is provided on all internal procedures and relevant regulations. Even more relevant for pharmacists in the pharma sector, I would say that 80% of my skillset was developed on the job. In particular, I was driven by my personal passion for pharmaceutical science, namely pharmacovigilance and public health. For example, to learn about pharmacovigilance, I created case studies and presentations for student conferences. Given my passion for public health, I recently completed an additional self-paced course at the Institute of Global Health in Heidelberg.
Sometimes, in the pursuit of a degree or a title, people may be more focused on the outcome and may engage less actively with the continuous learning process and mindset. However, it is not only ready-made knowledge that helps you excel and innovate. Rather, it is the individual hours you will invest in yourself, including searching and tackling new concepts and ideas. The pharma industry is dynamic and ever-changing. Therefore, unless you keep up, you may easily be left out of the loop.
3. What was your career path prior to your current role as a pharmacist in pharma?
From early in my training, my primary goal was to prepare myself both mentally and technically prior to stepping out of my student “bubble.” Apart from the mandatory training for my MPharm program, I also completed two additional placements. The first was in Quality Assurance at the Contract Manufacturing Organization FAMAR in Athens. The second was a clinical pharmacy specialization with a scholarship program at the University Hospital of Leipzig, Germany. The pharmacist's clinical input is fascinating to me, and I am an avid advocate for the important service pharmacistis can provide in the primary healthcare setting. I hope COVID-19 has shed more light into how pivotal our role and our expertise are in a multidisciplinary team of doctors and nurses.
My first full-time job was in Quality Assurance. Here, I specialized in cleaning validation, a critical process in drug manufacturing. This process ensures quality by preventing or minimizing the risk of cross-contamination with other products or microbial contamination. To do this, samples taken from manufacturing equipment are analyzed. In this role, I gained significant laboratory and drug manufacturing knowledge. In addition, I also collaborated closely with the Quality Control, Production and Packaging functions at our manufacturing plant.
Joining the pharma industry was not something I necessarily aspired to do or planned. Rather, the opportunity came up quite organically after a very positive experience I had during my internship at FAMAR. After about a year there, I went on to work in pharmacovigilance. This move was a conscious choice to realize my dream to work on adverse events and safety monitoring of medicines. My clinical pharmacy training was a plus in this position. My project manager position in Medical, Clinical and Commercial Quality is a blend of both my previous experiences.
In my career path so far, everything that I have done - even the most random projects - somehow fall nicely into place. The ability to transfer skills and insights from one role to another has proven advantageous.
4. What is the best or favorite part of your job? What is the most challenging part of your job?
During my first job, I remember loving the fast-paced and problem-solving nature of the work. Fortunately, I had the freedom to participate in many interesting projects. My favorite part was the variety in tasks and the cross-functional collaborations. This experience has really broadened my perspective.
The beauty of the pharma industry is that it offers intense skill-building through continuous exposure to demanding and collaborative projects. Such experiences open doors to opportunities within the organization. Therefore, pharmacists in pharma may have several different opportunities compared with what they may find in other professional settings. The pharma industry offers exposure to a lot of stimuli and individuals from diverse professional and cultural backgrounds.
In the majority of my jobs so far, I have had the opportunity to work with and familiarize myself with processes from a wide range of departments. This constantly adds to the quality and perception of my work. Plus, my current job gave me the chance to live abroad, integrate into a new culture and develop on a personal level. This is in addition to being able to contribute to projects in the field of rare diseases, about which I have grown very passionate.
The challenging parts include the workload and tight deadlines. Like in every role, some periods are stressful, and it can be difficult to keep a level head at all times and not get carried away with long hours - let alone during COVID-19 times when “bringing work home” went to an entire new level! The boundaries between meetings, tasks and personal time became blurry. Therefore, for optimal balance, I had to work on stricter, more consistent prioritization and find peace with leaving some projects behind. Other than that, in most of my roles, there are strong elements of communication and coordination. When this includes multiple stakeholders, it is a process that needs a lot of patience and diplomacy.
5. What are the skills/characteristics required to be successful as pharmacists in pharma? Is formal pharmacy training required for your current role?
Flexibility, versatility, good communication skills, creativity and being able to think on your toes - the latter is vital during audits. An audit is a comprehensive review of the entire quality system, facilities and related procedures. Customer companies can initiate audits, or health authorities can require audits in the form of an inspection. Such audits include interviews with the subject matter expert in each area. Sometimes, it can be a smooth discussion, while other times, it may become an intense atmosphere, where quick thinking, effective communication and negotiation skills are essential. Inspections from health authorities, for instance, can be particularly pressing and stressful. We take these audits and inspections seriously, as they are the means to confirm compliance to quality standards.
Other than that, finding effective solutions to solve problems under a tight schedule, while maintaining a long-term approach in your thinking, is definitely something that can make a Quality department very robust and successful. In my experience, the more diverse a team is, the better the outcomes. A diverse team will have a broader perspective of pain points and potential solutions. And of course, the more experience you gain, the better you become. Solid knowledge of the pharmaceutical legal framework and of the spectrum of good practices is surely an advantage of my formal pharmacy training, which I leverage in many of my tasks.
6. What is your advice for pharmacists in pharma or those who would like to pursue a career like yours?
Build a continuous improvement mentality early on, grow your skills with diverse projects and invest in building meaningful working relationships actively by seeking mentors and people who are willing to share knowledge with you. I cannot emphasize enough the importance of keeping in touch with colleagues and nurturing these relationships of mutual respect and support. The people I met have been a guiding force in my pursuits and my work ethic.
Most importantly, be aware of your goals and your wishes at any given moment and don't fear change. When we graduate, most of us do not have a clear idea of what comes next and what we want. My advice would be to embrace being uncomfortable and unsure in those early years rather than risk trapping yourself in a path you might feel safe on for only theoretical career success.
One of my mentors recently told me, “Careers are very long.” Therefore, take your time and be open to experiencing new areas and to exploring options that were not in your initial plan. I have colleagues who started in regulatory affairs but ended up finding their passion in health communication or marketing. Personally, having a curious and direct approach in asking to be involved in interesting projects has been a leading factor in getting my foot in the door on many exciting areas. I am always looking forward to what might come next for me.
7. What do you wish you knew now that you had not known before joining pharma?
I think the fast pace of pharma and the competitive culture that prevails sometimes may feel like a strong current for a young professional. Building resilience in the face of competition and rejection and setting clear boundaries both on our time and our psyche - what we let get to us - is something that we must develop as early as possible. This is a work still very much in progress for me.
One misconception I had was that pharma is a very corporate and formal world. Being a very casual and informal person, my introvert self had concerns about fitting in, which in hindsight were unnecessary. I was lucky to be able to be myself and express myself freely with all my employers so far. This gradually made me more confident and brave in my demeanor.
Finally, I recently finished reading Malcolm Gladwell´s Outliers, a very insightful book that emphasizes that opportunity is a primary player in succeeding in anything - whether career or personal goals. Talent, hard work and persistence - all are elements common to people we admire. However, opportunity is this one thing that can take you to the next level or bring a major shift. And opportunity doesn´t come on its own or by chance. We need to create our own opportunity with our individual arsenal and then go get it!
More about Maria
Maria Mantziri is a pharmacist with industrial and clinical experience in the EU. Her main areas of expertise are in pharmaceutical quality and drug safety. Her professional experience focuses on clinical and medical quality assurance, drug manufacturing and pharmacovigilance.
Maria earned her pharmacy degree from the University of Athens (NKUA) with a thesis in the field of pharmaceutical chemistry. She pursued further clinical training at the Universitätsklinikum Leipzig and a Quality Management and Patient Safety course from the Heidelberg Institute of Global Health. Maria received several scholarships throughout her studies and internships, and she maintains an active presence in congresses, journals and pharmaceutical webinars.
Maria is a strong supporter of and contributor to international mentoring and diversity, equity and health education programs. She is a member of multiple non-profits, non-governmental organizations and academic institutions.
Thank you, Maria, for an insightful post! This will surely be helpful for pharmacists in pharma and others who are interested in understanding more about jobs in quality within the pharma industry.