Job Description

NNIT is one of the world’s leading consultancies for the past twenty years serving the Life Science industry around the world. We apply the latest advances in technology - such as IoT, AI, Virtual Reality, Augmented Reality, Data Analytics - to make Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes more effective and efficient for our clients. NNIT has grown by more than 1,000 people globally over the last four years, and we are rapidly expanding our US Operations.

We are currently seeking a Quality Risk Management Manager to join our team.

Team Function

Team has developed in past 2-3 years performing risk assessments in response to:

• New or modified processes that may impact drug quality, patient safety, or compliance with FDA regulations
• Quality incidents involving internal Gilead processes or CxO (Contract Organizations where x = Manufacturing normally)
  

Risk assessment involves applying tools like FMEA (failure-mode effects analysis) to analyze how current or proposed processes can impact on quality & business risk.

On classifying risks- objectively & subjectively determining which risks need mitigation (i.e. a corrective action or change is needed).

Agreeing actions with stakeholders and ensuring those actions are implemented and have been effective (i.e. using Gilead QMS to ensure tracking and formally documenting effects).

Improving Gilead executive visibility into quality & process risk through development of metrics, dashboards, etc.

Scope of team is currently expanding to include measurement, reporting, and mitigation of many more areas of risk e.g. supply for critical materials; IT infrastructure risk; even recruitment / on-boarding / training risks- all will flow under the expanded scope for this team.

Role Function Within Team

To be able to act as an independent representative of the team- leading Risk Assessment groups comprising of: process engineering; manufacturing management; quality assurance; packaging; shipping; IT (from inside Gilead or partner organizations).

Serve as backup to the team lead (a Gilead Assoc. Director).

The Role Requires

• Significant experience in pharmaceutical manufacturing & quality assurance (basically must understand the pharma value chain… how an issue in one area can affect downstream processes)
• Confidence / “strength of character” to be able to lead teams of senior & mid-level management who will all have strong views of their own i.e. a typical challenge would be… people running down “rabbit-holes”
  

This role must be able to apply good judgment on what level of detail makes sense for the situation. The RA Manager cannot be dogmatic in adhering to a process or procedure when the results defy commonsense.

Must be able to persuade others- regardless of title- of the best-paths forward- but without igniting interpersonal disputes.

The Main Skills Of The Person Include

• Critical thinking skills above all else (synthesize large amounts of complex – and sometimes contradictory- data; challenge for credibility / veracity without causing offense; identify likely root causes based on the data; propose credible & effective solutions to issues)
• Excellent written communication skills (at least on par with those of our deviation authors)
• Having a solid understanding of statistics, software development / scripting, data science would be valuable.
• Must have strong skills of persuasion / influencer (in Myers-Briggs terms… ExTP type)
• Would not be someone who is afraid to speak up or speak-truth-to-power just because a consensus is developing to do something that doesn’t make sense.
• Must have the ability to push-back with diplomacy
• Intellectually sharp- but not dogmatic. Must be able to place problems in their wider context to understand what is a critical issue and what can be lived-with or even accepted without remediation.
  

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest and value-adding in everything we do. Whether it’s our weekly Friday meetings for all of our US employees, or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities, as well as providing them with “stretch assignment” opportunities to gain experience in new areas. We encourage employees to work at our client sites to maximize NNIT’s value and are also open to working remotely when possible. We strive to have a good work-life balance for all of our employees.

Apply today and find out the types of career opportunities NNIT can offer you!

NNIT is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you require accommodations to apply for this or any of our roles due to a disability. please contact jqhk@nnit.com