POSITION SUMMARY
The Head of Quality Control (QC) is responsible for managing an organization performing chemical and microbiological release testing on Raw and API materials used in the manufacture of Drug Products, as well as release and stability testing on Finished Drug Products.
POSITION RESPONSIBILITIES
- The Head of QC will report to the Site Quality Lead and be a key member of the site Quality Operations Leadership Team.
- Reporting to the Head of QC will be the Quality Control Laboratory Managers and staff level QC scientists.
- The Head of QC will be accountable for the efficiency, accuracy and service levels of the QC laboratory and is expected to support daily operations and budget.
- The successful candidate will be responsible for development and reporting of various metrics related to QC laboratory operations.
- The Head of QC will also be expected to initiate & lead process improvement projects.
- The Head of QC is expected to learn and manage other responsibilities as assigned.
- The Head of QC will be expected to represent the QC laboratories on projects within the site, across the company, and externally.
- The Head of QC will act as an integral part of on-site audits by customers and regulatory bodies, including review of analytical data, providing overviews of lab systems, CAPA identification and closure, etc.
- The successful candidate should be familiar with electronic systems used within the QC laboratories.
TECHNICAL SKILLS REQUIREMENTS
- Strong experience in current Good Lab Practice (cGLP) and Good Manufacturing Practice (cGMP) environments.
- Demonstrated strengths in the following capabilities : leadership, operational management, data and financial analysis, decision-making, critical-thinking and technical skills pertaining to operational excellence, negotiating, and conflict resolution.
- Good understanding of Lean Six Sigma principles and tools.
- Demonstrated record of innovation, focus on performance, change management, continuous improvement, and development / implementation of best practices.
- Proven history of effective performance management, coaching, mentoring of team members.
- Excellent computer skills including Microsoft Office, Outlook, and ability to learn Zoetis systems.
EDUCATION AND EXPERIENCE
Bachelor of Science degree in Microbiology / Chemistry or related science discipline with a minimum of 12 years relevant experience.
Advanced degrees are also considered but not required.
- Demonstrated leadership of high capability professionals and overtime eligible (OTE) colleagues
- Prior supervisory experience is required. The candidate must be prepared to lead a large organization, and specifically be able to succeed by working with / mentoring multiple front-line-manager direct reports.
- Six Sigma Green Belt Certified / Black Belt preferred.
- The successful candidate must be very familiar with cGMP standards.
- Strong interpersonal, teamwork and problem-solving skills. Motivated, self-starter.
- Excellent oral and written communication, as well as strong technical and analytical problem-solving skills are critical.
This position requires leadership / project management ability and a dedication to meeting timelines.
- Demonstrated record of achievement of objectives and proven demonstration and commitment to the Zoetis Core Beliefs.
- Demonstrated ability to interact with various levels of the Zoetis organization.
- Experience in the Pharmaceutical or Animal Health industry is a plus.
PHYSICAL REQUIREMENTS
The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the colleague is regularly exposed to both office settings and a manufacturing environment, including moving mechanical parts.
- The work conditions for this position include stationary activities as well as standing and walking throughout the workday.
- The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety ( steel-toed ) shoes, eye protection, gloves, and protective clothing.
- Candidate must not be Cephalosporin / Penicillin sensitive.