Director of Technical Services

Summary

This position is full-time located in the Fairfield, NJ office. Some travel will be required. The job involves leadership of Quality Control, Quality Assurance, and Regulatory Affairs. This position will also be involved in our Global business development program.  This position reports to the President and also work closely with corporate leadership.

Responsibilities

·      Quality Control / Assurance

• Develop and implement quality policies, procedures, and objectives to ensure goals are achieved
• Develop and implement industry-specific quality standards to ensure compliance with customer and regulatory requirements
• Lead and manage the Quality Assurance and Quality Control team
• Utilize statistical analysis to identify opportunities for improvement in processes
• Analyze and report on quality metrics, trends, and performance
• Establish and maintain relationships with customers, vendors, and regulatory bodies to ensure adherence to standards
• Monitor supplier performance and evaluate supplier auditing processes
• Serve as a liaison between the organization and external parties
• Develop and implement quality training programs

·      Regulatory Affairs

• Act as an in-house regulatory expert, advising and supporting, all countries associated with Garonit Pharmaceuticals (NA, Europe, and Japan)
• Lead the implementation of global regulatory strategies taking into consideration the overall development program objectives.
• Manage and monitor preparation, submission and review of regulatory documentation in collaboration with all regulatory filings (DMF/ANDA/NDAs/PDMA/CEP)
• Provide regulatory support to our global customers. Proactive leadership that supports our customers.

·      Business Development

o  Monitor process for new product development

o  Plan and review all Finished Dosage Filings

o  Involved in procurement of ANDA/NDA’s

Qualifications

• Strong working experience with a variety of regulatory authorities is required, with real firsthand experience of managing registrations with different regulatory authorities
• Must have experience in preparing and filling ANDA , NDA application with US FDA
• Experience in leading and managing complex/virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
• Proven track record in influencing and shaping optimal quality and regulatory outcomes
• Experience with FDA and other regulatory authorities
• Proven ability to work effectively in a team environment
• Professional experience as part of a regulatory agency would be useful
• Excellent knowledge of Quality and Regulatory environment (ICH, different regulatory mechanisms and authorities, GCP, GLP and GMP)

Education & Experience

·      Bachelor’s degree in science (Master’s in discipline would be preferred).

• Minimum 12 years’ quality and regulatory experience in the pharmaceutical industry

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Benefits

·      Health Insurance

·      Dental Insurance

·      Vision Insurance

·      401K

·      Paid time off