Manager, Quality Assurance - Clinical 8/10/2016
Pacira Pharmaceuticals Inc
JOB DESCRIPTIONAPPLY DESCRIPTION
The primary responsibility of this position is to assure compliance of the clinical programs at Pacira Pharmaceuticals, working closely with the Clinical Department to create, implement and evaluate the ongoing clinical programs and ensure compliance with Regulatory requirements. The position additionally will provide Quality oversight for Pharmacovigilance responsibilities within the organization and Pacira Headquarters in general. This Quality Assurance Manager will be the primary liaison between the Quality Assurance Department and other compliance driven functions at Pacira Headquarters. The position will also be responsible for implementing Clinical Quality Assurance Plans to include external GCP audits of clinical vendors, CROs, suppliers, and investigator sites, as well as internal audits of trial master files, and clinical and pharmacovigilance processes and procedures.
RESPONSIBILITIES (Including but not limited to):
* Provide Quality Assurance oversight to Clinical and Pharmacovigilance functions and demonstrate a customer driven approach to ensure internal customer expectations are met and exceeded.
* Perform a wide variety of activities to ensure compliance with applicable regulatory requirements associated with Clinical development and Pharmacovigilance programs.
* Create and author Standard Operating Procedures (SOPs) as needed to support compliance.
* Conduct external GCP audits and follow up of clinical/pharmacovigilance vendors, CROs, and suppliers.
* Conduct Investigator site audits and follow up for applicable clinical trials.
* Conduct internal process audits and follow up for clinical and pharmacovigilance functions.
* Works directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
* Ensures compliance with current global regulatory standards as well as internal standards, processes and procedures.
* Interfaces with Pacira s Clinical and Pharmacovigilance departments to address documentation and compliance issues.
* May interface with regulatory agencies as required.
* Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
* Assist with regulatory inspections and partner audits.
* Ensure corporate compliance with pharmacovigilance regulations including training and periodic audits.
* Ensure timely completion of commitments from regulatory agency inspections and partner audits.
* Ensure timely completion of Corrective and Preventive Actions (CAPAs) as needed.
* Other duties as assigned.
* 8 to 10 years of relevant Pharmaceutical Industry experience with a minimum of 4 years of GCP Quality Assurance experience.
* BS/BA degree in scientific discipline from an accredited college or university or equivalent experience.
* Ability to manage projects and responsibilities independently.
* Strong knowledge of GCPs and their application.
* Ability to use Microsoft Word and Excel applications.
* Ability to work proactively and cooperatively with managers and operational staff to solve quality problems.
* Ability to manage multiple responsibilities with a high degree of self motivation.
* Good written, oral and interpersonal communication skills.
* Understanding of Clinical programs.