Senior Manager, Quality Technical Services

 Kymanox - Company site
 November 19, 2021
 Morrisville North Carolina 27560 United States

PERMANENT, FULL-TIME JOB OPENING:

Manager/Senior Manager, Quality Technical Services 

Reports to Associate Director, Quality and Compliance

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

Region(s):

Research Triangle Park, NC Area preferred

Remote acceptable

Timing (Subject to Revision):

Applications: December 2021 to January 2022

Interviews: December 2021 to January 2022

Start Date Range: January to February 2022

Required Educational Background:

Bachelor of Science in Scientific or Engineering field (Chemical, Biomedical, or a related discipline) from an accredited institution. Advanced degree or industry certifications (e.g., ASQ, ISO) preferred, but not required.

Required Experience:

  • 9+ years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sectors is essential.
  • 1+ years of Supervisory or Managerial experience preferred
  • Possesses a diverse background relating to pharmaceuticals, biologics or gene/cell therapy development, medical device development, and/or drug/device combination product development.
  • Strong experience with one or more disciplines within Quality including, but not limited to, Quality Assurance/Compliance, Quality Management Systems, Quality Control, or Quality Engineering.
  • Direct knowledge of statistical analysis and related tools and programs.
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation.
  • Possesses a strong business acumen and ability to engage, build, and maintain strong client relationships.
  • Experience with contract manufacturing organizations and/or contract development organizations is a plus.

Job Description:

  • Directly support and provide subject matter expertise related to quality event investigations, such as those arising from non-conformances or deviations associated with manufacturing or supply chain activities, out-of-trend (OOT) or out-of-specification (OOS) events, and product complaints.
  • Support and make recommendations for corrective or preventive actions (CAPAs), including all associated records and effectiveness checks.
  • Directly manage a team of investigators supporting multiple clients/projects.
  • Interface with client Quality, Manufacturing, and Supply Chain subject matter experts on a routine basis.
  • Mentor associate level staff to help accelerate their growth and performance, including training in root cause analysis, out of trend identification, identifying data integrity and documentation errors, and other tools and methods.
  • Author, format, and review procedures, methods, manufacturing records, sampling plans, specifications, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practices.
  • Provide quality oversight and subject matter expertise for Quality-related change requests and product impact assessments resulting from investigations.
  • Provide regular updates to functional area management to facilitate timely decision-making and prioritization of project activities and deliverables.

Desired Aptitude and Skill Set:

  • Strong Leadership/Interpersonal, Communication, and Organizational Skills
  • Experience with Project/Program Management
  • Fluency with Root Cause Identification and Statistical Process Control
  • Resourceful
  • Self-directing, self-pacing, fast learner
  • Excellent written and oral English communication and presentation skills
  • High energy level
  • Appreciation for variety
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

Career Advancement:

The position will evolve over time and responsibilities will be added based on performance. Since Kymanox is a growing, dynamic company, there will be ample opportunities for advancement – both within the currently defined role, within the other internal groups, and roles to be defined in the future.

Estimated Travel:

Local travel within the assigned region and surrounding areas is required. Up to 30% remote travel may be required from time-to-time.

Compensation:

Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for the incentive “Shares” program.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, and other benefits.

Application:

All applications must be submitted via our website at www.kymanox.com under “Careers.” All applications are processed to ensure candidate confidentiality and data security. All applicant resumes are kept on file for one year.