Associate Director\Director Quality Complaints

Company Name:
Directs and oversees product complaints associated with commercial and clinical investigational products.in accordance with mandated regulatory requirements and site expectations. Will require involvement with higher level complex complaint investigations. This position will report to the Sr. Director of Quality Assurance.
Essential Duties and Responsibilities include, but are not limited to, the following:
Manage and develop the group responsible for handling product complaints for commercial and clinical investigational products.
Interaction with customers through senior management during complaint process.
Becomes involved as required to meet schedules or resolve problems. Will require involvement with higher level complex complaint investigations.
Interaction with the Pharmacovigilence group to correlate Adverse Events.
Interprets compliance requirements for incorporation into company systems/procedures.
Participates in regulatory and customer audits.
Actively participate in company continuous improvement initiatives.
Identify gaps in complaint handling process as it relates to reporting, metric, trending to maintain seamless compliance and develop feasible plans for correction
Development and oversight of robust reporting and metrics trending; prepare written reports to management on findings and is integral in the process of developing corrective and preventative actions associated with findings.
Involvement with investigations and/or product complaints with focus on Root Cause Analysis (RCA).
Knowledge and Skills:
Capacity for strategic thinking and the ability to translate and implement strategy.
A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Knowledge of pharmaceutical/biotechnology process so as to be able to make appropriate decisions.
Knowledge of MS word, Excel, database management and statistical analysis.
Effectively organize and manage work responsibilities of self and reports independently.
Strong interpersonal, written and oral communication skills
Good time and project management skills with the ability to multi-task.
Experience with documentation and quality systems.
Ability to communicate effectively and successfully manage conflict.
Working knowledge of KT investigation model, Root Cause Analysis (RCA), Hazard Analysis and Critical Control Point (HACCP).
Working knowledge of Kaizen processes.
Experience and Required Skills:
Education and Experience:
Requires BS/BA in scientific discipline or related field with a minimum 10-12 years of relevant work experience in pharmaceutical or related industry.
Previous experience with complaint handling practices is a must.
Certified Quality Engineer (a plus).
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