Quality Control Supervisor

Durham, NC, US
Jul 16, 2021
Quality, Quality Control
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Quality Control (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The QC Supervisor will be primarily responsible for overseeing testing which is performed by the QC Analysts. In this role, they will supervise a team of QC Analysts. Additionally, the QC Supervisor will review data, perform administrational duties associated with a leadership role, and actively perform testing if needed.

The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired.

  • Oversee the daily activities within the QC department in an efficient manner, assuring that the Novartis Gene Therapies core values (Integrity, Tenacity, and Teamwork) are reinforced.
  • Perform mid-year and end of year evaluations.
  • Lead and coach a team of QC Analysts.
  • Drive testing efficiencies in order to reduced testing time and costs, improve compliance, and reduce safety risks.
  • Perform equipment repair.
  • Assure training is up to date for the team.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Support strategic proposals, progress updates and presentations to all levels of the site organization.

  • Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience with 6 years of relevant experience in GMP testing laboratory preferred.
  • Working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action orientated and compliant minded.
  • Prior leadership experience is desired but not required.
  • Prior experience testing in a GLP environment is required.
  • Investigational stills with respect to laboratory investigations required.
  • Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
  • Must be proactive, action oriented, and have the ability to adapt to change.
  • Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • Must have strong communication skills both verbally and written.
  • Must have proven logic and decision-making abilities, critical thinking skills.
  • Must be able to accommodate testing schedule as required.
  • The ability to effectively communicate at all levels of the organization is required.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.