Job Title: Senior Quality Assurance Manager
Date Posted: 06-13-2008
Job Location: Massachusetts-Boston
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 5+ to 7 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Oscient Pharmaceuticals
Contact Information: Oscient Pharmaceutic   Oscient Pharmaceutic (hrjobs@oscient.com)
Job Description:
At Oscient Pharmaceuticals, you will be part of a growing company with an innovative
atmosphere, competitive benefits and an exciting future. For more information on becoming part
of the team, check out the job listings and the benefits overview at www.oscient.com/careers. 
EOE M/F/D/V.

Oscient Pharmaceuticals, which was formed through the merger of Genome Therapeutics and
Genesoft Pharmaceuticals, is a biopharmaceutical company committed to the clinical development
and commercialization of important new therapeutics to address unmet medical needs. The Company
is marketing FACTIVE® (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of
acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to
moderate severity. In addition to the oral tablet form, Oscient Pharmaceuticals is developing
an investigational FACTIVE intravenous formulation for use in hospitalized patients.

The Company is also promoting Auxilium Pharmaceuticals’ TESTIM® 1% testosterone gel to primary
care physicians in the U.S. Oscient has a novel antibiotic candidate, 

Ramoplanin, in advanced clinical development for the treatment of Clostridium
difficile-associated diarrhea (CDAD).

The Senior Quality Assurance Manager is responsible for establishing and maintaining Oscient’s
quality system and to ensure adherence by company and 3rd party manufacturers to Good
Manufacturing Practices and applicable international standards and guidelines in support of
commercial products and clinical trial materials.

Key Responsibilities:

-          Establish SOP’s and ensure implementation and adherence in Oscient quality system

-          Review raw material test data, stability data and finished product data

-          Review both internal and external documents (including SOP, Exception, Stability
report, investigation report, batch record, validation protocol and reports, specification,
etc.)

-          Maintain change control management system to ensure all Oscient initiated and
vendor initiated change captured and documented

-          Maintain Oscient CAPA system and resolve outstanding issues

-          Review and disposition completed production batch record, lab data and other
quality documents

-          Manage product complaint system and respond to customer complaints

-          Assist and support regulatory inspections

-          Establish and maintain vendor files including consultant files

-          Ensure quality projects and report completion meet established target date

-          Perform internal training and monitor training requirements for all operational
staff

-          Manage SOP system and initiate annual review

-          Maintain QA monthly metrics reports and monitor trends

-          Perform internal and vendor audits and follow up on observations

-          Maintain approved vendor list

-          Perform other duties as assigned or required to accomplish GMP compliance

Requirements:

-          Bachelor’s degree in life sciences 

-          Minimum of 5 years experience in compliance and quality improvement in
pharmaceutical industry

-          Strong organizational skills, ability to prioritize and make decisions based on
judgment and experience

-          Self-starter with high energy level able to work independently

-          Ability to work effectively within cross-disciplinary teams and vendors.

-          Computer proficiency in Microsoft Office, etc.

 

Oscient is not accepting unsolicited resumes from search firms for this employment
opportunity. All resumes submitted by search firms to any employee at Oscient via-email, the
Internet or directly to hiring managers at Oscient in any form without a valid written search
agreement in place for that position will be deemed the sole property of Oscient, and no fee
will be paid in the event the candidate is hired by Oscient as a result of the referral or
through other means. Note: Any search agreement entered into with Oscient 'prior to January
2005 is hereinafter void.

Search firms are essential to the recruitment and staffing efforts at Oscient and we value the
partnerships we have built with our preferred vendors. For this reason, Oscient has established
and regularly maintains a preferred vendor list. Please note that even preferred vendors need
to have a written search agreement signed by an officer of the company in place for the
specific position in order for a fee to be paid for any candidate referrals.
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