Associate Director, Quality Assurance GCP/GLP - REMOTE

Proclinical is seeking a remote Associate Director, Quality Assurance GCP/GLP with a biopharmaceutical company. In this role, you will be responsible for actively supporting the implementation of GCP and GLP (e.g., Bioanalytical) initiatives and for leading the execution of quality activities essential to the successful conduct of Clinical Studies/Programs.

Job Responsibility:

• Develop and implement Quality Programs where needed.
• Develop and implement risk based GCP and GLP audit strategies across clinical programs and/or studies. Emphasis will be placed on GLP Bioanalytical studies and support of Oversight of Clinical and Nonclinical Bioanalytical Laboratories.
• Manage and/or actively support the development, enhancement, review, and implementation of GCP and GLP 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 GCP and GLP vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program.
• Plan, conduct and manage audits of specific clinical/nonclinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.g., reports, corrective actions), with an emphasis on GLP/GCLP topic areas. 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 Study Management Team (SMT) members and other internal stakeholders to manage clinical/nonclinical vendor and/or clinical site oversight and/or issue management.
• Conduct and/or facilitate investigations of GCP and GLP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventive action plans, as applicable, with an emphasis on GLP/GCLP subject matter expertise.
• 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:
  • Project Management activities for Inspection Readiness initiatives.
  • Complete Inspection Readiness activities including preparing internal teams, clinical sites and significant clinical/nonclinical service providers.
  • 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/Nonclinical 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/nonclinical quality and compliance related training to internal functions. This may include coordination efforts in training events delivered by r external consultants.
• Provide GCP and/or GLP 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.

Skills and 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 in supporting Research and Bioanalytical Groups in managing GLP Nonclinical Toxicology and/or Nonclinical/Clinical Bioanalytical Studies and/or providing oversight of service providers providing services and deliverables in these areas.
• 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 GCP/GLP Quality Assurance auditing experience is required.
• The ideal candidate will embody The company's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• In-depth knowledge of and ability to interpret and apply GCP and/or GLP EU, FDA and ICH regulations and guidelines.
• Prefer candidates with certification in a QA-GCP or QA-GLP functional area such as the following: SQA Registered Quality Assurance Professional (RQAP) certification, ASQ Biomedical Auditor, or ASQ Certified Quality Auditor.
• Strong working knowledge/experience in planning, conducting, and reporting clinical site and service provider audits.
• 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.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
• This role will require proof of vaccination status to perform onsite, face to face work or to become employed.

If you are having difficulty in applying or if you have any questions, please contact Eddie Emery at (+1) 619-754-8547 or e.emery@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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