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Associate Director of Quality Assurance Job
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| Employer Name: Rising Pharma Holdings Inc. |
SpiderID: 13812959 |
| Location: East Brunswick, New Jersey |
Date Posted: 8/13/2024 |
| Wage: |
Category: Quality Control |
| Job Code: |
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Job Description:
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
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Rising Pharma Holdings Inc. |
Company Type: |
| Company: Rising Pharma Holdings Inc. |
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| City: EAST BRUNSWICK |
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| State: New Jersey |
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| Zip: |
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