Eastern Potential. Western Performance.

Job: Quality Assurance Director


Quality Assurance Director


China, Quality

Reporting To

Vice President of Quality


Suzhou, China


This position is responsible for Quality Assurance Manufacturing Operations, Operational Support, Documentation Control / Quality Release functions and Commercial Manufacturing related Quality Systems for In-Process operations sampling/auditing support.

Specific Responsibilities

  • Provides cGMP commercial manufacturing facility compliance support: Development, Validation, Maintenance, In-Process QA auditing-sampling of Product, component Material Release functions/activities
  • Provides QA support of the following teams/processes: Development, Validation, Maintenance, training, Document Management Systems, ongoing routine manufacturing audit-sampling support, general QA support of the Plant Quality Systems and/or compliance auditing activity. Reporting, tracking and follow-up of deficiencies / CAPAs noted.
  • Oversees and manage / maintain the cGMP manufacturing and/or manufacturing related documentation and ensure its integrity for executed Quality Records and document retention
  • Participates in and/or manage the Operational and/or Operations related Quality Systems Improvement Projects as assigned;
  • Works directly with Amerigen departmental peers, QA team members, with monitoring/follow-up and facilitation of CAPA and CAPA related action items pertaining to cGMP compliance quality problem investigations. Work with and support operational team members in facilitation / monitoring status with timely processing on CAPA action item activity to closure. (for all operations compliance / related activity);
  • Be responsible for the QA operations cGMP compliance training. Support operations and operational support groups/teams.  Overall QA team mentoring and member development.
  • Assists management with participation in on-site regulatory agency and/or compliance audits.
  • Other related duties as assigned by supervisor.

Desired Skills & Experience

  • Bachelor or above in Pharmaceutical or Chemical;
  • At least 10 years solid working knowledge and work experience in quality management in a USFDA cGMP Manufacturing Pharmaceutical environment.
  • Experience in the management of, development of and motivation of a multi-level-skilled QA Team functioning in a Team Based environment.
  • Strong compliance leadership and team mentoring skills, Strong ability in building consensus and help to influence compliance and compliance related decisions,  ability to effectively plan – organize and communicate improvement initiatives / ideas in a dynamic cross-functional environment.
  • Solid problem solving skills. (i.e., ability to Compile, Analyze,
  • Recommend and execute appropriate CAPA initiatives.
  • Strong Time Management and Organizational skills.
  • Strong Communication Skills in both written and verbal.
  • Fluent in English.

Apply Now

Suzhou Pharma Services

In China:
No.58, Qunxing Yi Road,
Suzhou Industrial Park, PRC. 215006
Contact: Julie Gu
+86-512-6745-1085 ext 101

In the US:
9 Polito Ave, Suite 900
Lyndhurst, NJ 07071
Contact: Michelle Valsera
(732) 993-9827