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Manager/Sr. Manager, Quality Assurance

Manager/Sr. Manager, Quality Assurance

Zhejiang Hisun Pharmaceutical Co. Ltd. was established in 1956 and currently employs over 9,000 people and is a public trade company (stock code 600267). Hisun’s vision is to become a widely respected international pharmaceutical company by advancing its mission of persisting in pharmaceutical innovation for the benefit of human beings. 

Hisun Pharmaceuticals USA, Inc. was established in 2009 and is a wholly owned subsidiary of Zhejiang Hisun Pharmaceutical Co. Ltd. We are dedicated to the global expansion of Hisun. Our team is comprised of industry experts in drug product sales & marketing, Business Development, Regulatory, Clinical Research, supporting our international customers. Currently we have several openings in the quality assurance, regulatory, and marketing areas in our New Jersey Office.

Job Description

 

Manager/Sr. Manager, Quality Assurance 

 

This position will manage the Quality Assurance function at Hisun USA to ensure adherence to and compliance with established company quality policies, practices, SOPs and federal regulations as well as the quality of drug products purchased, shipped, and/or distributed by the company. The key responsibilities include but are not limited to the following: 


Duties and Responsibilities

 

  1. Management of Hisun USA quality systems:
  • Maintain and continue to optimize the quality management system of Hisun USA
  • Manage of SOPs, GMP documentation, job aids and training
  • Responsible for quality related training program for Hisun USA employees
  • Management of indexes for GMP system
  1. Quality support for USA distributed product
  • Responsible for product release from manufacturers, CMOs, and business partners, coordinate and manage all quality assurance activities including product complaint, return, recall, disposition, pharmacovigilance oversight, etc.
  • Esurance of product printed materials for Hisun USA products
  • Notification to Management to manufacturing site for product quality issues.
  • Oversee pharmacovigilance and drug safety
  • Notification review and trend the FDA compliance trends. Identify areas in the market where there maybe new availability
  • Key GMP Processes – worked with manufacturers understand the inter-dependencies between Hisun USA and manufacturing sites for Product Distribution, Complaints, Returns, Field alerts and recalls.

  1. Vendor Qualification and Management – Audit, qualification and monitoring of CDMO/CMOs, partners’ manufacturing sites, CROs,3PL Warehouse, Return Facilities, Pharmacovigilance service providers

  2. DSCSA Compliance – oversight for the integrated and DSCSA compliant modules
    • Assure that DSCSA remains compliant and ready for regulatory requirements.

 

  1. FDA Inspection –
    • Coordinate and run FDA inspections at HisunUSA
    • Support regulatory inspections at manufacturing facilities
  2. Global Compliance Support:
  • Provide support for Regulatory Inspections
  • Subject Matter support for global Quality with Investigations, Root Cause, CAPA and Investigations writing
  • Provide manufacturing site with product Annual Product Review information.

 

Experience and Qualifications

  • Bachelor’s or higher degree in pharmacy, chemistry, biology, or other life sciences.  
  • Minimum 5 years of US experience as a quality professional in a pharmaceutical quality environment.
  • Current knowledge of cGMP’s in the pharmaceutical industry, especially with finished drug products, and distribution of pharmaceuticals.
  • Extensive knowledge of, and ability to establish quality systems and quality documentation.
  • Previous supervisory experience preferred.
  • Excellent verbal, written, computer, and technical communication and presentation skills.
  • Proven ability to build positive, collaborative relationships with different levels of the organization and clients, customers, and providers (i.e. CMO, CRO, 3PL, etc.).
  • Direct experience in leading audits with regulatory agencies.
  • Ability to effectively manage multiple priorities and deliverables within an entrepreneurial work setting. Ability to prioritize, and schedule work to meet personal and organizational deadlines. Knowledge and experience of when to escalate issues.

 

BENEFITS

As a member of the Hisun Pharmaceuticals USA team, you’ll find an environment that celebrates diversity and encourages the open exchange of ideas.  We are proud to offer an attractive salary along with a generous benefits package including employer matched 401(K) program, medical, dental, vision, and life insurance packages.

 

CONTACT

Interested candidates should submit their resumes to hong.zhao@hisunusa.com


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