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Michael Bohane, QA Manager
Biological, Chemical & Pharmaceutical Science

Michael Bohane, QA Manager

Michael Bohane works as a QA Manager for Teva Pharmaceuticals Ireland based in Waterford. Following his Leaving Cert he did a BSc and then a MSc in Biochemistry in UCC. He also did a Diploma in Pharmaceutical Manufacturing Practice (QP Qualification) allowing him to function as a QP and release product to market.

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first question!

What were the main 'career decision' milestones in your life so far?

I was always interested in science in school so I studied Biochemistry in UCC to MSc level. I started work in the Biopharm industry in the laboratories, eventually moving to a number of different multinational companies gaining experience with different product formulations and different market regulatory requirements.

I have travelled extensively in the US and China as part of my previous roles developing project management experience and team building experience. This work gave me an insight into the business aspect of the pharmaceutical industry.

All these experience led me to the decision that I would like to manage people or groups in a pharmaceutical environment.

Who are the people who most influenced your career direction?

My parents encouraged me to follow a career in science with chemistry sets etc as I grew up, so pursuing a science degree in college was a natural next step.

I would say that the person who influenced me the most in the working environment was the laboratory manager in my second job with a pharmaceutical company in Dublin. I was working as a senior chemist reporting to this person. Her style was direct, enthusiastic but she also gave people room to make their own decisions and develop. I still base my management style on this person.

How did you go about getting your current job?

I was contacted by a recruitment consultant who described the role and enquired if I was interested. I expressed an interest and an interview was arranged. I was interviewed by HR and my current boss. It was a general interview exploring pharmaceutical experience to date, general interests etc.

I was invited to attend for a second interview, again with HR and my current boss. This was a more specific interview based on the star interview model (situation, task, action taken, result). I was presented with a number of situations (20-30) to describe what was the action I had taken and the outcome. Th recruitment consultant then arranged a medical test and reference check.and I was informed in a number of days that I had been successful and the company would like to make an offer. The company contacted me directly and made an offer. I had some extra requests and these were met. I accepted the role. The entire process took about two months.

Describe a typical day?

My role can really be divided into two sections - R&D projects and manufacturing. Each day I have tasks relating to both sections of my role. I manage approx 30 people who have different responsibilities within each of these two sections of our company.

I spend time monitoring progress on the various projects that are ongoing at any one time. Each project has a time line that must be met to ensure the projects deliver products to the market on time to keep us competitive. My role would be to remove any compliance / regulatory roadblocks to the time line that may arise. I need to make decisions or suggestions that maintain the timeline and ensure product quality , safety and efficacy are maintained. We could have up to five development projects running at one time. A lot of time is taking up with project meetings to review progress etc.

We are also a manufacturing facility manufacturing product for up to 50 different markets. My group is responsible for the review and release of the product before shipment. Each day I meet the staff involved and review shipments for the week and any deviations that have occurred which might affect the product. I need to decide if the product is affected and needs to be rejected. If this is the case it must be reproted to the site and investigated to ensure it cannot happen again. We work to a shipment plan which must be met each week. We also have improvement projects to deliver each quarter which have to be managed.

What are the main tasks and responsibilities?

My main ares of responsibility are;

  • Ensure the Quality, safety and efficacy of all product manufactured and released
  • Ensure all process are validated
  • Facility, process and equipment validation
  • Work with R&D to ensure all development projects meet the requirements for quality and compliance
  • Department budget control
  • Site regulatory compliance
  • Customer complaint management and investigation
  • People management and development
  • Vendor and internal auditing

What are the main challenges?

Main challenges in my role are:

Time management & people management - when managing a group of people there is always a variety of different needs and approaches. The team works best when all feel they can contribute in their way etc and this needs to be accommodated

Technical - I need to stay abreast with changes in the regulatory environment in Europe and US especially. The pharmaceutical are is highly automated and I need to be familiar with the manufacturing processes so any decision I make is sound and based on good science.

What's cool?

Getting problems solved and corrective actions implemented so I am confident I will never see the issue again. Managing a group of people and seeing the group succeed in achieving its objective

What's not so cool?

Budget control. In the pharmaceutical industry the financial aspect of running the dept is very important and all spend has to be controlled.  Budget compliance is reviewed monthly with the finance group and this can be quite tiring having to justify spend to non-science people whose sole focus is bottom line (which they need to be of course).

What particular skills do you bring to your workplace?

My particular skills are:

  • I am technically sound, I understand the regulatory environment and also the manufacturing processes used to manufacture our products
  • I have good experience in problem solving using various methodologies
  • I believe I have good people skills, being able to relate to the different people types you meet at work
  • I have good project management skills

What subjects did you take in school and how have these influenced your career path?

My Leaving Cert subjects were Irish, English, Maths, French, Chemistry, Biology and Business Organisation.  My main interest was science so I chose two science subjects and one business related subject to keep things interesting.

My subjects were appropriate for my University course except I was required to take Physics in the first year. This was quite challenging not having taken Physics to Leaving Cert but not impossible. I don't think I would do anything differently if I had to repeat the process.

What is your education to date?

Leaving Certificate - Irish, English, Maths, French, Chemistry, Biology, Business Organisation

BSc (Hons)
Biochemistry MSc
Biochemistry Diploma in Pharmaceutical Manufacturing Practice (QP Qualification) - this allows me function as QP and release product to market. Only a QP can release product within the EU. It is a two year course.

What aspects of your education have proven most important for your job?

The QP course (Diploma in Pharmaceutical Manufacturing Practice) is the most important course for my role. Of course you need a primary degree to be eligible for the course and my postgraduate qualification definitely helped me to get on the course in the first place. I would not have been considered for my current role without the QP qualification.

What have been the most rewarding events in your career so far?

The most rewarding event was the successful PAI audit with FDA for a novel new product in a previous company I worked with. A lot of effort went into the preparation for the inspection and its success was very pleasing.

What personal qualities do you have that helps you in your career?

The qualities that really help me in my job are being a good listener. It is very important to hear and understand what people are telling you about issues they are facing and may impact on the products we manufacture. I am decisive in my decision making based on the information we gather from experts in the process.

What is your dream job?

A job that makes a difference to people and their lives, e.g. paramedic

Does your job allow you to have a lifestyle you are happy with?

My current role allows me to maintain a healthy work / life balance. I have a family with four children which takes up a large amount of time. I am active in a number of sports especially rugby and triathlon, also time consuming. I have progressed in my career satisfactorily so far but I would still have ambitions to progress further.

The company I currently work with encourages such ambition and allows people to seek responsibility and develop. It is important for a company to reward good / excellent performance and I am fortunate to work for such a company. Financial reward, while not being the most important aspect, is still important. My current role within the pharmaceutical industry pays well especially since I gained the Qualified Person qualification in 2001.

What advice would you give to someone considering this job?

Be prepared for responsibility and the rewards and problems that come with responsibility. It is very important to be comfortable making decisions and living with them. While it is impossible to be right all of the time the majority of decisions you make have to be correct.

What are the three most important personal characteristics required for the job?

Technical knowledge and ability to analyse problem using this knowledge.
Good listener.
Good organisational skills.

Have you undertaken, or do you plan to undertake any further training as part of your job?

The QP course was undertaken through distance study while working in a previous role. I intend to study for an MBA within the next two years. The course will enable me to understand the business needs of the company and meet these requirements.

What kinds of work experience would provide a good background for this position?

You need to gain experience in a regulated environment like the pharmaceutical industry. That is vital.

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