Description

Manager, Quality Assurance Compliance (cGMP)

Optimer Pharmaceuticals, Inc. is seeking an experienced Manager, Quality Assurance Compliance (cGMP) to actively participate in all activities of our Quality Assurance programs. The successful candidate will be responsible for the quality assurance and cGMP compliance for all manufacturing/testing sites, packaging and other duties assigned by the Director of Quality Assurance and Analytical Development. You will also provide support of identifying and achieving key company, operations and departmental strategies, tactics and objective for product quality and cGMP/GLP compliance. Assist with preparation for FDA and other compliance audits.

MAJOR DUTIES AND RESPONSIBILITIES:

Assist with preparations for FDA and other compliance audits.
Prepare and/or review/approve investigations, deviations, CAPA, change controls, batch record release, protocols, SOPs and any other reports as needed.
Provide support, guidance and training to Product/Analytical Development team.
Develop goals and objectives for the department in alignment with the corporate goals and objectives.
Assist annual budget preparation to meet company goals.
Develop and execute an audit plan and coordinate the cGMP compliance audits.
Oversees work performed by contractors to ensure meeting compliance.
Evaluate significance of audits findings and coordinate the findings responses with the contractors.
Participate in CMC meetings by presenting the regulatory compliance responsibilities and plans for sponsor audits of sites.
Review CMC documents including, but not limited to, protocols, amendments and reports for adequacy and compliance.
Maintain current knowledge of cGMP/GLP regulations and company policy and procedures.
Participate as a liaison during relevant negotiations and/or inspections.
Write and review SOP for the QA department.

Requirements

EXPERIENCE AND/OR EDUCATIONAL REQUIREMENTS:

Bachelors degree in Chemistry, Life Science, nursing or related field.
Minimum of 5 years of QA and auditing experiences in a cGMP/GLP/GCP/ pharmaceutical environment or equivalent with pharmaceutical sponsored clinical research, including PAI experiences.
Extensive knowledge of cGMP regulations, ICH guidelines for CMC.
Excellent communication, organizational, interpersonal and computer skills.
Ability to identify compliance issues, communicate issues to others and identify resolutions effectively.
Supervisory and management experience.
Ability to travel (minimum 25-50%).

Interested candidates e-mail resume:
careers@optimerpharma.com

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Pruvel (prulifloxacin) is an antibiotic which has completed two Phase 3 clinical trials for the treatment of infectious diarrhea in travelers. Additional information can be found at http://www.optimerpharma.com.