Senior Manager, GCP Quality Assurance

Employer
Retrophin
Location
San Diego, California
Posted
Sep 26, 2020
Ref
R-100062
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary:

The Senior Manager, GCP Quality Assurance is responsible for actively supporting the implementation of GCP initiatives and for leading the execution of clinical quality related activities. This position will manage 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 Retrophin's Clinical Development Programs and continuous process improvement.

Essential Functions:

  • Develop and implement Quality Programs where needed.
  • Contribute to the development of audit strategies and implement them 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 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.
  • Lead or actively support the development and maintenance of key Clinical Quality Metrics for input into process improvement initiatives and/or Senior Leadership presentations.
  • 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.


Qualifications:

  • Bachelor's degree in related Life Sciences discipline is required; advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • 6+ years in drug/biologics development in the biotechnology or pharmaceutical industry.
  • 5 years previous GCP Quality Assurance experience in Clinical Research and Development is preferred.
  • Minimum of 4 years of Quality Assurance auditing experience is required.
  • 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.
  • Experience in GLP auditing a plus.
  • 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.


Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer