Director, Quality Assurance

Position Title: Director, Quality Assurance Department: Quality Assurance
Reports To: COO Work Location: East Brunswick/Somerset, NJ
Position Summary:

Provide an overview of the role, including job scope / responsibilities, impact, decision authority, problem solving, level of influence, etc.

The Director of Quality Assurance will direct and manage the day-to-day activities of the QA team at Rising Pharma Holdings, Inc. doing business as Rising Pharmaceuticals.  This position plays a key role in assuring that the proper quality frameworks are established at the stages of both business development and commercial operations.  Additionally, the position requires a willingness to “roll up your sleeves” and engage hands on in substantive QA work, as well as the ability to effectively work collaboratively with other departments.  The Director will work closely with the Regulatory, Business Development, Supply Chain, Sales, and Operations departments. The Director of Quality Assurance will actively manage the QA team, including 4 direct reports.
Essential Duties & Responsibilities: Quality Assurance
• Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategic objectives of the Company
• Directs and coordinates internal quality activities of documentation, incoming inspection, certificate of analysis and labelling reviews, annual product reviews, complaint, and adverse event monitoring
Demonstrated experience directing cross-functional teams to manage contracts and partner sites for development, manufacturing, packaging, testing and release of the Company’s commercial and pipeline projects.
• Directs supplier qualification program and manages external quality activities of CMOs in accordance with quality agreements
• Maintains 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
• Conducts due diligence and ongoing supplier audits, as needed
• Acts as subject matter expert with regards to all QA practices and procedures for the company as a whole
• Monitors the company’s compliance through internal and external audit programs, and provides technical and compliance oversight to the audit team
• Writes and reviews SOPs and oversees document and change control processes
Essential Duties & Responsibilities: Leadership
• Provides planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed
• Provides leadership in developing and implementing QA strategies and processes to ensure consistent high quality of all products
• Ensures that interfaces between QA and other departments, particularly Regulatory, BD, Supply Chain, Operations, and Sales are managed optimally
• Provides subject matter expertise to business development and sales teams to influence selection of partners and business decisions
• Manages decision making and conflict resolution with regards to compliance related activities
Position Requirements:
Education:
Required: M.S. or higher in related fields
Experience:
Required: • Minimum 10-15 years’ experience in QA for pharmaceuticals distribution and manufacturing and drug substance (API) manufacturing, specifically in Generics

• Capable of organizing and executing successful agency milestone meetings and with track record of successful relationships with one or more health authority

• Ideally also a significant external network at least into other generic/API/pharma companies and recognized as an expert broadly or in specific areas of regulatory affairs

Specialized Training or Technical Knowledge Licenses, Certifications Needed:
Substantial domestic and international drug product vendor qualification and/or certification audit experience, including extensive working knowledge of 21 CFR 111, 211, 21 CFR 314 and ICH Q7
Company / Industry Related Knowledge:
Generic pharmaceutical knowledge
Job Specific Competencies:
• Keen analytic, organization and problem-solving skills
• Excellent teamwork, communication, analytical and leadership skills.  A “team player” attitude is a must
• Must have the ability to interact effectively at all levels of the organization, as this position will have significant exposure to senior management
• Strong interpersonal skills and experience in effectively communicating key data to internal departments and customers
Physical Requirements: N/A

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