Sr. Director – Quality
| Company | KBI Biopharma |
|---|---|
| Location | Durham, NC, USA |
| Salary | $205000 – $282700 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required.
- A Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered.
- At least 15 years of regulated pharmaceutical industry experience.
- Must have thorough knowledge of cGMPs and biotechnology-derived product regulations.
- Demonstrated track record in regulatory inspection management, strong orientation for Quality and Customer Service, strong collaboration and team building skills, support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies, demonstrated level of respect for individuals, high level of integrity and personal responsibility, record of innovation, experience developing, implementing, and executing strategic plans and objectives for organizations and departments.
Responsibilities
- Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives.
- Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
- Key contributor to long term strategic planning and part of senior leadership team.
- Work with internal and client teams to establish Quality strategy, define roles, and problem solve.
Preferred Qualifications
- CMO experience preferred.