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October 1999


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Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Thu, 21 Oct 1999 12:27:05 GMT
text/plain (88 lines)

An opportunity that was mailed to me last night.

Scott Sutton


We are seeking two individuals, one for a VP position the 
other a director position. Title: Vice President 
Quality/Regulatory Affairs Reporting Relationship: President 
and CEO Position Summary: The Vice President of 
Quality/Regulatory Affairs will provide leadership for 
compliance with quality standards and regulations and 
facilitate the continuous improvement of process and 
production quality. He will supervise the following 
departments: 1) Quality Control 2) Quality Assurance 3) 
Regulatory Affairs 4) Validation Technical Support and 
Engineering Responsibilities: 1) Direct the Quality Unit in 
accordance with the Quality Unit Character. 2) Manage, 
recruit, train, develop and motivate RA/QA/QC personnel. 3) 
Establish and staff an effective Quality Assurance/Regulatory 
Affairs Department. 4) Create measures for product and 
process quality and provide these data to senior management. 
5) Define objectives, standards, priorities, and tasks regarding 
product and process quality. 6) Develop proactive approach to 
quality function in the organization. 7) Coordinate and 
integrate the quality groups to attain maximum result. 8) 
Provide direction and guidance concerning regulatory and 
quality aspects for the development of new injectable 
products. 9) Oversight for Curacao maintenance up.ado and 
modernization. 10) Institute programs for continuous 
improvement of Regulatory Affairs product quality and 
services. Education: Ph.D in microbiology, biochemistry, 
protein chemistry or other appropriate life science field of 
study. Experience: Minimum of 7 years of active involvement 
in Regulatory Affairs regarding FDA related products. 
Director Quality Assurance & Compliance REPORTING 
RELATIONSHIP: Vice President, Quality/Regulatory Affairs 
POSITION SUMMARY: The Director Quality Assurance & 
Compliance will be responsible for quality assurance and 
compliance activities associated with the manufacture of 
pharmaceutical products for Advance Biofactures Corporation 
and RESPONSIBILITIES: 1) He/She will be responsible for 
the day-to-day operation of the department and for 
establishing the department''s overall priorities, objectives, 
standards and measures at the Lynbrook, Curacao and Knoll 
Pharmaceutical Facilities. 2) Ensure that products are of the 
quality required for their intended use, including compliance 
with cGMP and other drug regulatory requirements. 3) Ensure 
the quality procedures and policies are developed and 
implemented. 4) Provide training for QA personnel in the 
application of procedures and policies. The incumbent must 
also make sure that all procedures and policies are current and 
in compliance with cGMP. 5) Document the quality system 
encompassing the organizational structure, procedures, 
processes, resources, and systematic actions with clearly 
specified responsibilities. 6) Perform and document annual 
product reviews which will include: IPC, QC results, products 
out of specification, failed processes, changes, stability 
studies, complaints, recalls, corrective actions, and necessary 
re-validations. 7) Develop and manage a vender qualification 
system, including procedures for vender audits. 8) Ensure that 
process equipment and cleaning validations are in compliance 
with approved SOPs EDUCATION; BNBS Degree in the life 
sciences field of study. EXPERIENCE: A minimum of 5 years 
experience in QA in the pharmaceutical industry including a 
minimum of 2 years in a supervisory role, 

Geographic Location of Position: New York

If you know anyone that might be interested, please forward 
this to them or contact:

Larry Chiaravallo
Diedre Moire Corporation, Inc.
Fax: 609-584-9575
Email: [log in to unmask]

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