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| Reference: |
2821 |
| Date Posted: |
4/21/2008 |
| Organization: |
Sterling-Hoffman Life Sciences |
| Employment Type: |
Full Time |
| Location: |
Virginia, USA, VA |
Description:
Our client is the API production division of a well-respected global pharmaceutical company. The company's growth has outpaced the industry for a number of years and they boast both an experienced management team and a commitment to maintaining a world-class corporate culture. This is a great situation for a candidate that is pursuing a challenging opportunity with the potential for career advancement.
Job Responsibilities:
1) Lead and direct the development and implementation of quality policies, systems and procedures
2) Ensure that company complies with all regulatory guidelines
3) Develop and implement regulatory strategies, policies, procedures and optimal infrastructure to ensure site-wide compliance with all regulatory agencies (e.g., FDA, DEA and EMEA)
4) Ensure timely and accurate preparation as well as recording of all regulatory submissions and documentation, including batch records, DMFs, etc., for high-quality regulatory submissions
5) Oversee, lead, serve as host and liaise for all regulatory as well as customer audits
6) Provide direction and leadership in the area of customer complaints
7) Ensure that customer and regulatory authority requirements are met
8) Provide leadership in the area of controlled substance compliance
9) Design, implement and improve effective strategies (e.g. quota procurement and management)
10) Ensure company compliance in the manufacturing and reporting of all controlled substances
11) Provide overall direction, research and consultation with regard to all regulatory, compliance and quality matters (within the site)
12) Act as the company liaison for all quality and regulatory activities on both the internal and external level (i.e. within the company and with all regulatory bodies, like the FDA, DEA, EMEA, etc.)
13) Ensure that there is no company product supply disruption due to regulatory non-compliance or enforcement action
14) Guarantee that company’s quality processes are in agreement with corporate quality guidelines and procedures
15) Instill the values of the company quality process throughout the organization
16) Create and maintain a corporate culture, which emphasizes prevention, conformance to requirements as well as continuous improvement
Job Requirements:
1) Ph. D. in Chemistry, Chemical Engineering or a related discipline
2) Minimum 10 years of experience in managing or implementing quality systems and processes in any pharmaceutical industry (except medical devices)
3) Experience in managing a quality group of 25+ people
4) In-depth knowledge of cGMP, DEA regulations, FDA regulations and Q7A
Applicants are encouraged to apply directly by going to:http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02821.html
Salary: $160k-$180k
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| Healthcare Field: |
Biotechnology |
| Category: |
Clinical Quality Assurance Auditor |
| SubCategory: |
None |
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Job Posted By:
Similee Harvey
Sterling-Hoffman Life Sciences
800 West El Camino Real ,Suite 180
Mountain View
United States
94040
View more jobs posted by Similee Harvey |