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Global GCP Audit Strategy Lead

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POST DATE 8/28/2016
END DATE 12/19/2016

A New Beginning - Genesis 2 San Francisco, CA

San Francisco, CA
AJE Ref #
Job Classification
Full Time
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This position is responsible for contributing to the design and implementation of the risk-based audit and quality assurance oversight strategy covering the GCP regulated activities for internal processes/regulated systems, service providers, and therapeutic area programs/studies.

This role monitors the GCP processes and activities through periodic risk assessment, risk-based routine audits, and provides ongoing support to the business in the review of mitigating actions. It also provides actionable data to Senior management based on analysis of data (audit/inspection/risk) and identification of trends.


*Design and implement the Global risk-based Strategy for audit and quality assurance activities.
Contributes to development of risk assessment methodology and maintains related tools/procedures.
Define/maintain the "audit/risk universe" of processes/systems/service providers/studies/programs.
Performs risk assessment to determine which audits will be conducted and where risk mitigation activities should occur.
Develop and implement a risk based strategy to deliver an audit program and quality assurance oversight model.
Assess specific risk areas on an ongoing basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary
Deliver strategic rationale and objectives for GCP audits, collaborating with Lead Auditor.
Act as a point of contact for audits, review audit related documents and support lead auditor.
Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks.
Contribute to development of communication tools (reports/dashboards) for audit and inspection metrics and trends.
Escalate significant compliance issues to PDQA Management.
Lead or participate in PDQA audits.

*Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues.
Establish strong partnership/relationship with business stakeholders.
Review and provide feedback on functional area risk mitigation plans/CAPAs.
Provide quality leadership on compliance issues and projects to the functional area and PDQA staff.
Support PDQ Partner Services in the implementation and oversight of QMS.
Manage 'for cause', critical, and or complex quality issues.
Provide education and/or training to PDQA auditors and business partners or study/project teams.
Act as trainer and mentor for GCP Strategy Specialists providing meaningful feedback on a person's performance in close collaboration with their line manager.
Support Inspection Management Team in preparation for and conduct of regulatory authority inspections.

*Contribute to the development and execution of PDQA goals and initiatives.
Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned.
Lead the development and/or revision of PDQA processes and procedures including SOPs, Work Instructions, and risk assessment tools.
Perform other tasks as assigned by line management.

*Maintains highest level of awareness, expertise in international GCP regulations and internal policies and SOPs.
Assess impact of new regulations and guidance on GCP activities.
Maintain in-depth knowledge of company policies, SOPs, and supporting documents related to drug development as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations that may affect drug development and post-marketing processes (as applicable).


*Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
*Advanced degree in referenced fields preferred.


*Minimum 7 years in pharmaceutical industry and/or quality assurance.
*Minimum 5 years in GCP related discipline.
*Demonstrated applied knowledge of GCP and/or pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
*Project management experience with proven leadership, mentoring and coaching.


*Proficiency in the conduct of GCP related audits.
*Experience supporting regulatory authority inspections.


*Experience, competency, and proven track record developing audit and quality oversight strategies in GCP areas.
*In-depth knowledge of drug development processes and GCP regulations.
*Ability to influence and negotiate effective solutions within PDQA and with business stakeholders.
*Ability to work in an international multicultural matrix organization.
*Ability to assimilate new and emerging compliance information or trends.
*Demonstrated ability to work both independently and in a team environment.
*Demonstrated strong analytical, problem-solving, and decision-making skills.
*Strong verbal and written communication (including presentation) and customer management skills.
*Demonstrated ability to effectively organize and execute tasks.
*Demonstrated ability to operate with a high level of personal leadership
*Computer proficiency.
*Fluency in written and spoken English required.
*Bi or multi-lingual skills desirable.


*Leading teams and acting globally
*Collaboration and teamwork
*Managing projects/programs
*Communicating and presenting

TRAVEL: up to 25%

Base Salary - $150,000 to $150,000
Benefits - Full
Relocation Assistance Available - Yes
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes

7+ to 10 years experience
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally

Visa Candidate Considered: Yes

Also, please understand this may take time for both of us working together to help advance your career. I will do my best for you and never charge you anything for our time and efforts.

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