Job Location : China ( 中国 )
Job Type: Permanent Full-time ( remote)
We are searching for an experienced Quality Manager for our office in China, The successful candidate should have strong quality assurance and management skills. The Quality Manager will be responsible for ensuring that the quality of GRP is maintained all the time and that GRP operations in China follow Good manufacturing practices. The Quality Manager will be responsible for the oversight of activities permed by third parties in China for GRP China, such as distributors, analytical laboratory and logistic companies. He /she will be responsible for partners’ selection, due diligence, establishing and maintaining quality agreements, reviewing change controls, releasing products, monitoring deviations and producing metrics.
This individual will also work closely with the GRP USA, clients and local partners in China.
- Maintaining relationships with local partners, developing and maintaining quality metrics.
- Supporting technology transfers, analytical method transfers, and process validation at CMOs in a quality role
- Releasing products in China.
- Reviewing Batch records, Deviation investigations and Change Controls.
- Reviewing vendor protocols and reports, including Annual Product Quality Review
- Auditing partners and performing their qualification.
- Attending routine business meetings as the quality representative
- Supporting external audits and inspections from customers or CFDA/ NMPA.
- Maintaining the quality system at GRP China.
- Develop and Maintain Quality Technical agreements
- Writing and updating QA procedures.
- Minimum, a BS degree in life sciences, pharmacy, or related field
- Minimum of 6-7 years of pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
- Good understanding of CFDA/NMPA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.
- Minimum 3-4 years of quality audit experience.
- Demonstrated teamwork, initiative, and problem-solving skills
- Demonstrated project management skills.
- Ability to prioritize and work independently with minimal supervision
- Ability to accurately determine deadlines and ask for help if needed
- Detail oriented with solid problem-solving acumen.
- Ability to work effectively in a team environment with great organization skills.
- Ability to independently analyze and reconcile moderate to complex issues.
- Must have demonstrated initiative and accountability in a fast-paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e., Microsoft Office products).
- Proficient in English (writing and speaking).
- Minimum Experience Level: 6-year
- Career Level: Mid-Career
- Minimum English Level: Daily Conversation
- Minimum Mandarin Level: Native
- Minimum Education Level: Bachelor’s Degree
- Visa Status: Permission to work in China required
- Age Limit: No Age limit for applicants
INFORMATION ON GRP
- Company type: International CRO
- Company Headquarters: USA
- Office Locations : China; Shanghai and Beijing ( 上海、北京)