Director of Quality Assurance & External Chemistry
Location: New Haven, Connecticut
Posted: November 25, 2016
Reference ID: 1184993879
A Director of Quality Assurance & External Chemistry is available in New Haven, CT courtesy of Adecco Medical & Science. This direct-hire opportunity is for a dynamic professional with strong experience in conducting external audits with rpharmaceutical facilities to pre- and post-qualify them to produce products at their facility. This Biotech/Pharmaceutical professional will be willing to do the work initially, and have the energy to grow this new part of the company. This means they will travel (25-40% in the U.S. and Europe) and be responsible for writing reports, conducting audits, releasing batches, writing processes, generating QA Agreements, etc. The role is expected to grow in an executive role as this division grows (in 12-18 months), this person will be a strong leader who can hire and build this team, and provide mentoring and strategic direction.
Qualifying external manufacturing facilities
Auditing suppliers' production (processes, raw materials, finished product, etc.)
Ensuring overall compliance (regulatory, quality assurance, etc.)
Bachelor's degree in Chemistry
7-10 years' experience in a QA, auditing, regulatory, pharmaceutical, manufacturing, etc.)
Strong knowledge of GCP, GMP, GDP, ICH, and FDA regulations
Required 'soft skills' include: energy, vision, management, leadership, communication skills, problem solving skills, strong initiative, etc.
To be considered for this position, please use the "apply now" button to submit your resume. If you have questions about the position contact Scott Shuman at 585.613.3028 or at email@example.com.