Associate Director of Quality Assurance Job

Associate Director of Quality Assurance is needed to perform the following duties:

• Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategic objectives of the Company.
• Direct and coordinate internal quality activities of documentation, incoming inspection, certificate of analysis and labelling reviews, annual product reviews, complaint, and adverse event monitoring
• Manage supplier qualification program and manages external quality activities of CMOs in accordance with quality agreements
• Maintain effective CAPA process and ensures timely follow-up and implementation of corrective actions.
• Responsible for overall planning and management of QA systems to ensure continuous sale of products consistent with established standards and regulatory requirements.
• Direct cross-functional teams to manage contracts and partner sites for development, manufacturing, packaging, testing and release of the Company’s commercial and pipeline projects.

• Provide planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed.

• Provide leadership in developing and implementing QA strategies and processes to ensure consistent high quality of all products
• Ensure that interfaces between QA and other departments, particularly Regulatory, BD, Supply Chain, Operations, and Sales are managed optimally Prepare management reports, defining and evaluating problems and recommending solutions.

• Assist in the review and revision of SOP’s, protocols, and special studies required for compliance with batch record. Assures compliance to SOP's and cGMP's for routine operations.
• Monitor the company’s compliance through internal and external audit programs, and provides technical and compliance oversight to the audit team.
• Manage decision making and conflict resolution with regards to compliance related activities

• Provide subject matter expertise to business development and sales teams to influence selection of partners and business decisions.
• Apply, Oversee and monitor regulatory adherence of certifying organizations/ guidelines.
• Responsible for timely completion of regulatory projects and submissions of documentation to regulatory agencies.
• Writes and reviews SOPs and oversees document and change control processes
• Review additional information/responses as requested by regulatory agencies.
• Ensure compliance to relevant regulations as standards by evaluating and addressing product/process changes and deviations from regulatory commitments.

Bachelor’s Degree is required in Pharmaceutical Science or Pharmaceutics or Pharmaceutical Manufacturing or Pharmaceutical Engineering