Associate Director, Quality Assurance Gcp

Position Summary:

The Associate Director, Quality Assurance GCP is responsible for actively supporting the implementation of GCP initiatives and for leading the execution of clinical quality related activities.  This position will lead Inspection Readiness Activities, assist with the management of the audit program, and partner with key clinical and cross-functional groups (e.g., Clinical Compliance, Clinical Operations, Biometrics, Regulatory Affairs) to ensure compliance of Clinical Development Programs and continuous process improvement.

Responsibilities:

• Develop and implement Quality Programs where needed.

· Develop and implement risk based GCP audit strategies across clinical programs and/or studies.

· Manage and/or actively support the development, enhancement, review, and implementation of GCP quality standards and controlled documents (e.g., SOPs, Work Instructions, Templates)

· Promote compliance and quality throughout the company and represent the Quality Department in internal meetings and events.

· Build, develop and maintain working relationships with internal and external partners.

· Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program.

· Plan, conduct and manage audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.g., reports, corrective actions).  For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.

· Partner with Clinical Compliance and other internal stakeholders to manage clinical vendor and/or clinical site oversight and/or issue management. 

· Conduct and/or facilitate investigations of GCP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventive action plans, as applicable.

· Partner with Clinical Compliance in the management of the inspection readiness program and regulatory inspection management while providing input to inspection-related process improvement.  This may include:

o Project Management activities for Inspection Readiness initiatives. 

o Complete Inspection Readiness activities including preparing internal teams, clinical sites and significant clinical service providers. 

o Lead cross-functional team to ensure a state of “constant” inspection readiness.

· Partner with Clinical Compliance for the implementation and management of Clinical Risk Management Program

· Lead or contribute to the development and maintenance of key Clinical Quality Metrics for input into process improvement initiatives and/or presentation to Study Management Teams and Senior Leadership.

· Lead the development and delivery of clinical quality and compliance related training to internal functions.  This may include coordination efforts in training events delivered by Clinical Compliance and/or external consultants.

· Provide GCP guidance to internal stakeholders or Study Management Teams, as applicable.

· Participate in quality and/or cross-functional process improvement initiatives, as applicable.

· Other duties as assigned by Quality Assurance Management.

Education/Experience Requirements: 

· Bachelor’s degree in related Life Sciences discipline is required; advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.

· 8+ years in drug/biologics development in the biotechnology or pharmaceutical industry. 

· 7 years previous GCP Quality Assurance experience in Clinical Research and Development and/or GLP auditing is preferred. 

· Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities.  Experience in managing inspection and post-inspection follow-up activities.

· Minimum of 5 years of Quality Assurance auditing experience is required.

Additional Skills/Experience: 

· The ideal candidate will embody core values: Courage, Community Spirit, Patient Focus and Teamwork.

· In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines.

· Strong working knowledge/experience in planning, conducting, and reporting clinical site and service provider audits.

· SQA RQAP registration a plus.

· Experience with Microsoft based applications and ability to learn internal applications/systems.

· Experience with eQMS systems is a plus.

· Ability to identify quality issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.

· Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

· Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.

· Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.

· Ability to travel 10-30% domestically and internationally. 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.