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US-CA-Irvine: Sr. Manager in biotech

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http://biotech.fyicenter.com

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Jan 10, 2012, 5:53:51 PM1/10/12
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US-CA-Irvine: Sr. Manager in biotech
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99890386_Sr__Manager_in_biotech.html
Date: 10-Jan-2012
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

Sr. Manager in biotech

Education equivalent to a 4 year college degree, with an emphasis in a
technical discipline such as Chemistry, Microbiology, Pharmaceutics or
Biochemistry. Additional scientific training M.S., PhD, and/or MBA a
plus. * Ten - fifteen years of QA/QC experience in pharmaceutical
aseptic manufacturing environment. Sound technical skills including
working knowledge of pharmaceutical production, quality assurance, and
analytical testing technologies. * In depth knowledge and experience
with cGMP/MOH requirements for Pharmaceutcal products in major markets
around the world (FDA, TGA, MHRA, etc.). * Experience with and ability
to manage and influence regulatory agency personnel at all levels,
both in field compliance and agency centers. * In depth knowledge and
experience with quality systems, corrective action and preventive
action system, statistical process control, quality risk management,
FMEA, DOE and other key tools for managing global quality performance
in the Pharmaceutcals arena. Essential Skills and Abilities:

* Excellent judgment and decision making capability in the technical
and compliance arenas. * Excellent analytical, interpersonal and
verbal/written communication skills, with both internal constituencies
and external regulatory stakeholders. * Integrity, judgment, and the
ability to hold one’s ground under pressure. * Ability to work in a
multinational, multicultural and highly matrix environment. * Team
player with strong customer orientation. * Ability to travel
approximately 20% of the time. * Knowledge and experience in
pharmaceutical product documentation procedures with proven ability or
project experience in developing systems and business processes to
improve overall efficiency and productivity. * Ability to influence
individuals that are outside the span of direct control (i.e.,
influence without authority). * Must have excellent Organizational
Skills. Must be detail and quality oriented. * Proficient in computer
skills and hands on experience in different computer software such as
database management, spreadsheets, project management, presentations
word processing flowcharting and/or any other similar type of
programming.


Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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