§ Performs Quality review of equipment installation, operation, and performance qualification protocols. Qualifications will be for production equipment (reactors, filters, ovens, etc), analytical instrumentation (HPLC/UPLC, GC, etc) and site utilities (HVAC, Purified Water, Nitrogen, etc).

§ Performs Quality approval of executed equipment qualification protocols.

§ Provides oversight of Supplier Management program. Ensures that required activities are completed

§ Assists in gathering site Key Performance Indicators (KPIs).

§ Provide audit assistance for regulatory inspections and routine customer audits. Assists management will providing responses and CAPAs to audit observations.

§ Works with other departments to develop and implement various trainings.

§ Provides oversight and performs internal audits.

§ Works on compliance related deviations/investigations, CAPAs and Changes as either owner or QA oversight.

• 
  BS in a scientific discipline or equivalent with a 6+ years’ experience in an FDA regulated industry.
• MS in a scientific discipline or equivalent with a 5+ years’ experience in an FDA regulated industry.
• Experience with Quality Assurance oversight.
• Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
• Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
• Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, supplier management.
• Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals. Experience mentoring and training staff members in a Quality department.

Skills/Experience Valued but not required:

• Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly.
• Excellent analytical, written and verbal communication and presentation skills.
• Strong technical writing skills and the ability to clearly express ideas in English.
• Ability to work independently and in a team environment
• Ability to positively resolve conflict

Flexibility for changes in work priorities

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.