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Associate Director GCA - Schering Plough
Dec 19
Location: Kenilworth, NJCategories: Research
Website: http://appclix.postmasterlx.com/track.html?pid=402881bd1e48ea6f011e4b88059105f8&source=fiercebiotech
Position Description
Shape Your FutureAnd Ours.
Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by our colleagues around the world.
Associate Director GCA
Requisition Number: 23518BR
The Associate Director, Global Clinical Audits is responsible for the implementation of the GCP quality assurance audit program for his/her region based upon the GCA global audit strategy. With oversight from the Departmental Head and close interactions with other regional GCA audit units, directs the planning and conduct of good clinical practice (GCP) quality assurance audits according to the GCP audit program. Identifies and allocates adequate resources for the conduct of audits and evaluations. Reviews and evaluates audit results for adequacy and assessment of the GCP unit training needs.
Develops monitoring of the audit program performance and identifies opportunities for audit program improvement and participates in development of Global Clinical Audits audit procedures.
Applies advanced technical skills in GCPs.
Provides quality and compliance guidance to client groups. Identifies trends in compliance issues and provides periodic feedback to management.
Major Roles:
50% Actively manages the planning and conduct of Global Clinical Audits audit program in the region the Associate Director is responsible for. Identifies and allocates adequate resources for the conduct of audits. Provides oversight and supervision to the designated auditing personnel. Maintains current schedule of audit activities and allocated audit resources.
Reviews project specific audit plans and coverage to assure adequacy and consistency with the overall GCP audit program objectives. Reviews and evaluates results of audit activities for adequacy of communication, relevance against the GCP standards, as well as quality and consistency within the group; identifies training needs for the unit. Develops training plans and participates in training and coaching of staff members.
Directly manages the work of audit team leaders. May act as a liaison between the audit teams and the auditees’ management. In addition, responsible for the following administrative functions:
· Conduction performance appraisals for direct reports and planning their professional growth and development. Review performance appraisals for indirect reports.
· Identifying and interviewing potential candidates for positions within the Global Clinical Audits unit.
· Proposes the budget needs for the unit and closely monitors the use of the budget by the unit.
25% Reviews results of audit program for identification of serious quality and compliance issues and communication/escalation to the management. May provide recommendations as well as guidance to a variety of business practice / compliance issues. Identifies trends in quality and compliance issues and applies expertise in assessing root cause and provides periodic feedback to management.
Collaborate with the other members of the GCA management team to ensure a harmonized, adequate and directed approach of GCA globally with respect to the conduct and reporting of audits, communication of audit results and interpretation of regulations.
Liaise with key stakeholders to ensure that audit results are clearly communicated and adequate corrective and preventive actions will be implemented. In order to achieve this, maintains close working relationship with the other units within GCQ&QMS.
5% Establishes monitoring and review of the audit program to assess whether its objectives have been met, including identification and monitoring of key performance indicators. Identifies opportunities for improvement and appropriate corrective and preventive actions for the audit program. Reports results of performance monitoring to management. Participates in development of Global Clinical Audits written procedures.
5% Appoint qualified personnel for implementation of the audit program. Ensure that appropriate training is provided to GCA personnel for auditor’s competence and proficiency with applicable internal and external standards, such as policies, procedures, guidelines and regulations.
5% Conducts or leads all types of audits performed by the unit, as needed.
Participates in “Due Diligence” reviews when GCP issues are key to licensing decisions and in investigations of suspected fraud, where applicable.
On request of the Global Inspections Operations group, conducts or leads activities in preparation for and during regulatory/health authority inspection, for example, pre-inspection assessments of clinical investigator sites, hosting a regulatory/health authority inspection, coordination of responses to inspectional observations and follow-up.
5% Maintains required knowledge level of applicable worldwide government regulations and their current interpretation as well as industry standards via participation at industry conferences and discussion groups relative to the regulations. Serves as a consultant to customer operations as is pertinent to GCP issues.
5% Provides or actively participates as trainer/presenter in training sessions for the applicable S-P business functions related to audit findings, GCP guidelines and/or (inter)national regulations.
Qualifications:
* Science degree required, advanced degree preferred in medical or life science discipline
* Minimum 8 years clinical research and development experience in pharmaceutical industry
* Minimum 5 years of GCP compliance experience
* Must have a thorough understanding of applicable global regulations/guidelines to facilitate the interpretation and impact of compliance concerns of internal and external audits
* Must be willing to travel worldwide, approximately 25%
* Experience in working with and understanding different cultures
* Minimum 3 years of management experience
* Strong analytical and interpersonal skills are required as well as excellent written and verbal communication skills
* Must be able to build strong relationship network within the Clinical Research and Operations organization to help with the identification of potential issues and prioritization of the audit activities
Schering-Plough is an equal opportunity employer. M/F/D/V
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