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Senior Manager of Quality Assurance, GCP (Biopharma) - 12171

TalentZok San Diego, CA
  • Posted: over a month ago
  • $115,000 to $145,000 Yearly
  • Full-Time
  • Benefits: 401k, dental, medical
Job Description

Senior Manager of Quality Assurance, GCP (Biopharma) - TalentZok

OVERVIEW

Are you looking for a new career opportunity with an exciting biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases?! THEN READ ON! In the role, you’ll be 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 the company’s Clinical Development Programs and continuous process improvement! Our client is offering top market compensation, generous bonus, excellent benefits, and RSUs! If this sounds good, let’s talk ASAP!

Immediate opening for a Sr. Manager of Quality Assurance, GCP in San Diego, CA who possesses:

  • Bachelor’s degree in related Life Sciences discipline

  • 6+ years in drug/biologics development in the biotechnology or pharmaceutical industry

  • 4+ years of Quality Assurance auditing experience

  • 5 years previous GCP Quality Assurance experience in Clinical Research and Development

  • 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

  • *preferred* experience in GLP auditing

  • *preferred* SQA RQAP registration

  • *preferred* experience with eQMS systems

  • *preferred* advanced degree

Email your resume to mturner@talentzok.com and call 858.356.6772

 

KEY RESPONSIBILITIES INCLUDE:

  • 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.

 

For immediate and confidential consideration, please email your resume to mturner@talentzok.com and call 858.356.6772

More information can be found at www.talentzok.com

Company Description
IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together.

THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater Los Angeles area - opportunities you won’t find on your own.

THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right.

THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.

TalentZok

IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater Los Angeles area - opportunities you won’t find on your own. THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right. THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.

Address

San Diego, CA
USA

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