Date Posted:

11/11/2008

 

Job ID:

1665

 

Company:

We are a specialty pharmaceutical company committed to developing new techniques to help physicians individualize patient care. We focus on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Company's' strategy includes the marketing and delivery of pharmaceutical products balanced by its proprietary, top notch diagnostic testing services. By integrating therapeutics and diagnostic services, company addresses the continuum of patient care, thus afford physicians with a across-the-board solution to treat chronic diseases.

 

Location:

Southern CA

 

Reports To:

Director of Quality.

 

Salary:

115-135K

 

Education:

Bachelors of Science or Masters degree in scientific discipline.

 

Requirements:

12 years relevant industry experience. At least 3 years direct responsibility for interacting with regulatory authorities and at least 5 years supervisory/managerial experience required. Strong familiarity with Code of Federal Regulations pertaining to pharmaceutical products required. Prior experience in the Diagnostics industry and/or working in a high complexity CLIA/CAP environment preferred. Computer skills competency including Excel, Word and PowerPoint programs.

 

Duties:

Responsible for developing and maintaining quality systems within the organization to ensure practices, processes and standards are in compliance with applicable regulatory guidelines. Assures pharmaceutical products and diagnostic services meet applicable requirements and authorizes product release for distribution Manages the internal and external audit programs to ensure compliance with regulatory requirements and internal procedures Develops and maintains strong and effective relationships with contract manufacturers, vendors and suppliers to insure timely and accurate communications. Alerts senior management of anticipated quality problems associated with the company s systems, products or services. Provides primary support for management review of the companys products and quality systems for compliance with FDA regulations. Assures satisfactory performance and completion of QA aspects of regulatory and business development tasks/activities including but not limited to clinical trials, supplies, development and approval of Standard Operating Procedures (SOPs), CAPA, deviations, change control, product complaints, annual product review, product labeling review, and product recall. Supports Quality management in the preparation, conduct, and follow-up activities resulting from interactions with regulatory and accrediting authorities. Leads the QA/QC due diligence activities in support of anticipated product development and/or acquisitions as applicable. SUPERVISORY RESPONSIBILITIES: Directly supervises members of the Quality Systems department. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding, developing, coaching and disciplining employees; addressing complaints and resolving problems. Proactively supports the organizations values and success factors.

 

Date Posted:

6/2/2008

 

Job ID:

1624

 

Company:

We are a specialty pharmaceutical company that provides contract R&D, manufacturing and analytical services to the pharmaceutical industry. As a pharmaceutical contract service provider, We are continually increasing the scope of the contract services we provide to meet the growing needs of our valued client partners. We can offer the full spectrum of pharmaceutical contract services from development to complete commercial toll manufacturing and analytical testing.

 

Location:

Texas

 

Reports To:

Senior Director of Operations and/or the COO

 

Salary:

100-130K

 

Education:

BS or MS in chemistry or equivalent science.

 

Requirements:

6-10 years of work experience working in chemistry, quality control and/or laboratory management positions; Extensive experience of and working with GMPs/GLPs. Internal contact: Daily contact with personnel from all departments of Company; Regular contact with management. External contact: Frequent contact with clients; Primary laboratory contact with FDA personnel; Primary company contact with other regulatory bodies. Direct supervision of laboratory groups – manufacturing support, stability, method transfer, laboratory services.

 

Duties:

The Director of Quality Control is ultimately responsible for managing personnel working in the area of Quality Control and their respective actions and projects. Responsibilities include the daily execution of activities as assigned, but not limited to, the following: Manage the quality control group for release and stability testing of finished products, in process testing, QC inspections and audits, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance. Manage the general quality control aspects of Company analytical laboratory, including conducting investigations and non-conforming events, ensuring adequate training and monitor training effectiveness for lab personnel. Manage and oversee daily laboratory activities and quality control chemists. Establish and manage quality control group for raw material testing (i.e. APIs, excipients, packaging components). Perform regularly internal lab audits to ensure GMP compliances. Participate in audits from outside companies and FDA. Coordinate with QA for QC data review, addressing comments from QA and/or clients, and ensuring the proper calibrations, qualifications, and preventive maintenance of lab instruments. Coordinate with manufacturing for weekly scheduling of testing. Coordinate with R&D group for transfer, qualification and validation of test methods into QC. Prepare, review and/or approve Standard Operating Procedures, technical reports, specifications, stability protocols, and QC analytical test records. Maintain the stability programs and stability sample reconciliations.