Eastern Potential. Western Performance.

Job: Quality Assurance Director

Title

Quality Assurance Director

Categories

China, Quality

Reporting To

Vice President of Quality

Location

Suzhou, China

Information

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
jgu@suzhoupharma.cn
+86-512-6745-1085 ext 101

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