Duties/Responsibilities:

=       Responsible for all internal and external activities of Quality Assurance & Compliance Department.

=       Oversee all daily activities in Department including scheduling, assigning, and managing QA staff and direct reports. Develop, implement, and continuously improve Quality and Compliance Systems consistent with FDA and other regulatory agency requirements.

=       Manage QA and Compliance systems to ensure raw materials and drug products meet company standards.

=       Oversee and manage internal and external audit and vendor/service provider qualification/audit programs.

=       Create and review GMP documents including SOPs, Annual Product Quality Reviews, risk assessments, supply chain map, and quality reports.

=       Oversee deviations and investigations (quality and laboratory) including root cause analysis and Corrective and Preventive Action (CAPA) proposals and initiatives.

=       Collaborate with cross functional departments including Product Development, Analytical and Quality Control, Operations, Regulatory Affairs, and Sales and Marketing departments to ensure timely submission of targeted products to FDA and timely launch of commercial products and distribution of approved products.

=       Manage all quality aspects of scale up, exhibit, process validation and commercial batches including enhancement.

=       Oversee, implement and enhance Quality training programs. Ensure departments follow Standard Operating Procedures (SOPs).

=       Release ANDA exhibit batches for regulatory submissions and clinical studies and release commercial products for distribution.

=       Review standards and specifications for raw materials, in-process and finished products.

=       Ensure full compliance with FDA regulations, including current Good Manufacturing Practices, current Good Laboratory Practices, and other applicable FDA and regulatory agency requirements.

=       Determine, check, and agree on in-house quality procedures in manufacturing, analytical, quality control, compliance, and research and development departments.

=       Oversee validation activities and IQ/OQ/PQ.

=       Prepare documents for regulatory submissions and address FDA deficiencies. Participate in FDA and other regulatory agency inspections.

=       May undergo background checks and drug screening.

Required Qualifications:

=       Must have Bachelors in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related field, 10 years relevant quality experience in generic pharmaceutical industry, and required skills (10 years’ experience). 

=       In the alternative, must have Masters in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related field, 7 years relevant quality experience in generic pharmaceutical industry, and required skills (7 years’ experience). 

=       Required skills include: GLP and cGMP documentation; developing and maintaining SOPs and pharmaceutical industry related documents; managing internal and external audit programs; interpreting and applying FDA regulations; and working within pharmaceutical industry’s legal rules and regulations.