Director, GCP

Description

This midsized cutting edge company located in the booming San Francisco Bay Area is in need of a Director of Global Clinical Development Compliance and Training. This company is looking for a high-level individual to assess the purpose, scope, and operations of the department and set strategic direction for development.

The Director is responsible for:

• Conduct of performance reviews and professional development needs of the CQA GCP personnel.
• Providing direction and leadership according to CQA Standard Operating Procedures (SOPs).
• Continued implementation and maintenance of a CQA Systems with written SOPs
• The annual CQA Audit Plan and its implementation
• Communications to and from the CQA management concerning corporate information and requirements
• Communications to and from the CQA personnel concerning related compliance to applicable standards, regulations, local and international
• Reporting CQA status to the V P of Quality periodically as scheduled and required or more often as needed
• Participation in any and all assigned corporate level meetings and teams
• Corporate training and presentations, including external meetings such as investigator meetings; or the assignment of qualified CQA personnel
• Clinical trials sponsored or co-developed are conducted and the data are generated, recorded and reported in compliance with protocols, SOPs, Project Plans, international requirements for Good Clinical Practice (GCP) and other applicable international regulatory and quality requirements.
• Escalation and reporting of any CQA compliance issues; and risk management
• Participates, hosts and responds to external and/or regulatory inspections pertaining to CQA

Essential/Primary Duties, Functions and Responsibilities:
Directing and Managing the CQA department:

Ensure development and implementation of the CQA annual audit/activity plan;

Reviewing and /or conducting systems audits, contracted audits, for-cause audits, vendor audits (e.g., GMP, GLP, Media storage, IRBs);

Maintaining latest industry expertise with regulatory requirements and provide consultancy on quality/regulatory related issues;

Supervises, supports and trains CQA staff in the execution of their functions by providing guidance;

Hosts and/or participates in relevant external and regulatory authority inspections;

Responds to and resolves issues relating to external audits and regulatory inspections performed; ensures that departmental staff and operational management are aware of the current and imminent regulatory requirements governing the conduct of studies and the suitability of facilities under the GCP Guidelines

Communicates and escalates situations of CQA corporate risk and serious clinical compliance observations; and follows to resolution

Submits reports to CQA and the VP of Quality relating to significant audit issues and trends and provide trending data from audit reports; Teach courses as requested, and trains Company personnel as appropriate;

Oversees and/or writes performance reviews; establishes goals and determines professional growth needs and opportunities, in collaboration with managers and CQA personnel;

Develops and manages CQA departmental budget;

Attends corporate meetings internally and in external investigator meetings as needed to present CQA Plans and GCP training.

Performs other duties as requested by Management

Work Experience:
Minimum of 15 years of increasing responsibility in pharmaceutical or related industry GCP-related Quality environment

Management of Staff:
Minimum of 5 yrs direct and indirect management level experience

Functional/Technical Knowledge & Skills:

• Candidate/Incumbent must have computer literacy in MS Word, Excel, and PowerPoint, and must possess oral and written communication skills in English.
• Previous project planning / budgetary management is desirable.
• Experience with EDMS and/or computerized medical records systems is highly desirable

Customer & Industry Knowledge:

• In-depth knowledge of applicable GxP regulations, FDA Good Clinical Practices(GCPs), FDA Good Laboratory Practices (GLPs), ICH Guidelines, FDA Regulations and Guidances, Appropriate Computer System Validation
• In-depth GCP auditing knowledge

Education/Training:

• Four year college degree (life sciences mandatory) and 8-10 years of relevant clinical development experience required. Nursing, medical technology or pharmacy education preferred.
• Continuing education to maintain any professional certifications.

Other Requirements:

• Strong organizational and management skills, attention to detail, communication/interpersonal skills, and professionalism required
• Comfortable working in a fast-pace environment with constantly changing priorities and activities
• Willing to travel up to 25%
• Proficient in Problem Solving and Quality Decision making
• Proficient in Quality Planning and Process/Time Management
• Skilled in management of a corporate department concerning planning of the annual budget and compliance within the budget
• Highly skilled in Conflict Management and Managerial skills
• Proficient in Negotiating and Communications skills

To find out more about Real please visit www.realstaffing.com