New heads of Quality Assurance come into pharma companies
all the time for various reasons. If you are the new head of quality, hopefully
you were able to get some sense for the reasons for the vacancy during the
interview process. I recognize that this is not always easy in an interview
I have heard such explanations as: we’re looking for a fresh
approach; we’re looking for someone with more of a business perspective; we’re
looking for a partnership with QA; we’re looking for an operations-oriented QA;
or we’re looking for a more progressive QA.
Actually, these all sound very positive and a highly
desirable situation for a new, enlightened head of QA looking for a challenge.
But like the Rorschach test, these explanations could be interpreted various
ways, some of which would be troublesome for the newbie who understands the
regulatory role of QA.
Rarely is the expectation as clear as one example in my own
career when a company president that interviewed me spoke very directly and
took out all the guesswork.
The interview lasted three minutes—because I ended it. The
president of the company said, “If you reject my product, blood will be let.”
After a moment of nervous laughter I understood him to be quite serious, and
that he was talking about my blood. I responded by plucking my resume out of
his hand, tucking it back into my briefcase, and responding, “Would you please
ask your admin to call me a cab?”
But there is no more popular reason for changing of the
guard than being the incumbent on whose watch the company received a Warning
Letter. The termination of the QA person is served up as a peace offering and
symbol of turning over a new leaf.
The problem with turning over a new leaf is that sometimes
it looks the same on both sides. The new QA head has the same struggles as the
former head of QA, because the issue was not one of understanding and applying
CGMPs, but facing a pervasive company culture of antagonism toward FDA
The FDA recognizes the possibility of antagonism when we
read in recent Warning Letters: “QA was either unable, or not permitted to
exercise its responsibility.” (See The QA Pharm 9/25/10.) However, neither is
an excuse, because you had the option to resign.
As the new head of QA, you want to make a positive
impression as a leader who can be trusted; who is a collaborator; who is a
builder; and who makes mindful decisions. So here are some suggestions on what
should you do before the honeymoon period is over.
1. Know for yourself the state of compliance.
Gather your own intelligence on the effectiveness of the
Quality Management System QMS) and the general state of regulatory compliance.
This should include CGMP compliance as well as compliance to the Chemistry and
Manufacturing Controls (CMC) of your drug application. Don’t rely on hearsay,
or solely on the results of previous inspections.
2. Establish a governance process.
Determine the appropriate performance metrics for each
element of the quality system that reports both how well the system is working,
as well as what the system is detecting. Report these in a decision-oriented
forum of your peers. Solve the problems at a lower level, if possible. However,
ensure that each problem rises to the appropriate level and person who has the
approval authority for the cost of the solution. Be sure you have allies in the
room. Document the decisions, even if the decision is to do nothing, or to
3. Build relationships with other
Build trust with your peers. Work together to identify and
resolve problems. Give credit to other areas when they identify problems and
come forward to resolve them. Don’t blindside a peer in a public governance
process. Offer to resolve problems that other areas have with inefficient
quality system processes.
4. Integrate the quality/ compliance plan
into the business planning process.
Develop a quality planning process based on the problems and
risks identified from the management review (governance) processes. Integrate
the quality plan with the normal business planning process.
5. Speak the universal language of money.
Resolving waste streams, rejections, and nonconformance,
etc. all have associated cost. Resolving these issues not only save money, but
improves quality and CGMP compliance. Never allow cost to enter your judgment
when making a market release decision; however, keep focus on problems that
improve the bottom line, and get the compliance for free.
6. Use the fine art of writing proposals.
Write proposals to improve the way of working, to implement
a new program, or to make a capital expenditure. Putting proposals in writing
helps you to make the case to support. Be sure to capture the return on
investment, cost avoidance, or risk mitigation. Shop your proposal to other
functional heads, and allow them to sign on to the proposal to signify support.
7. Strengthen the Quality function.
Make time to visit each functional head during the first
month of your tenure to ask: What does the quality function need to do more of?
What does the quality function need to do less of? Be willing to accept the
feedback. Loop back with each one to let them know your assessment of the
situation and the action you are taking.
I invite you to share your thoughts and experiences that
would benefit our readers, especially the person walking into a new QA
The QA Pharm