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 North and South American customers. Currently we have several openings in the quality assurance, regulatory, and sales & marketing areas in our Princeton Office.
Manager, Quality Assurance
This position will work within the Quality & Compliance Group at Hisun Headquarter and will manage the total 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
- Establish quality management system of Hisun USA.
- Coordinate and manage all quality assurance activities including deviation handling, change control, CAPAs, complaint, return, recall , adverse drug reaction and significant event report to regulatory agent and Hisun quality headquarter, etc within the highly regulated industry to ensure that Hisun USA objectives are achieved in compliance with federal, state, and company requirements.
- Responsible for managing all quality assurance activities supporting the quality systems at Hisun USA and its contract 3PL, wholesale customers, manufacturers/packagers where applicable.
- Responsible for quality related training program for Hisun USA employees.
- Provide oversight of regulatory/standards requirements for areas such as Food and Drug Administration (FDA) regulations for finished drugs (i.e. 21 CFR 211), Dietary supplements (21 CFR 111).
- On-site quality contact for audits, inspections by agencies (federal, state, etc.) and customers.
- Directly coordinate the incoming inspection of finished goods.
- Manage the quality document retention.
- Act as liaison between Hisun USA and Hisun Headquarter to ensure the continuity of one Quality system
Experience and Qualifications
- Bachelor’s Degree in a scientific discipline. Master’s Degree preferred.
- Minimum 5 years of US experience as a quality professional in a pharmaceutical or highly regulated environment in a 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, CPO, 3PL, etc.).
- Direct experience in leading audits with regulatory agencies. certified Quality Manager, Engineer or Auditor is a plus.
- 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.
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.
Interested candidates should submit their resumes to firstname.lastname@example.org