Senior Clinical Quality Assurance Manager - Redwood City

Location: United States - Redwood City

Function: Quality Management

Company: Relypsa

About You

Position Summary:

To report to the Head of CQA Auditing, the primary responsibility of the Manager is to oversee the management of all audits required for the clinical studies he/she is assigned to, and the conduct of internal and external GCP system and process audits.
Management and support of quality-related tasks and systems related to clinical studies (i.e. fulfil the responsibilities of the QM CMRS representative on the assigned Clinical Study Team/s)
Management and support of received GCP and GVP inspections and audits and by Regulatory Authorities and Third Party Contractors.
To support and comply with the organisation’s duty of care obligations, in relation to GCP and GVP functions.
To act as Subject Matter Expert (SME)and as the primary point of contact with clinical development and clinical operations teams to provide GCP and process related guidance and support; works with teams to investigate and resolve clinical study related GCP compliance, deviations and process related issues, providing recommendations for solutions and CAPAs as needed.
Maintains up-to-date working knowledge of regulatory standards and guidelines related to Clinical Quality programs
Promotes understanding, communication and coordination of Clinical Quality/compliance initiatives and standards.
 
Position Responsibilities:

  • Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
  • Independently conduct external & internal audits for QM CMRS (for PV this includes affiliate, commercial partners, internal systems and vendor audits).
  • Monitor audit responses and corrective action to ensure accuracy and completeness.
  • Auditing of directed and for-cause audits as necessary.
  • Act as CQA Auditing representative in designated study team/s (and back-up as required) and provide internal guidance and consulting for trial GCP issues.
  • Act as CQA Auditing representative (and back-up as required) for study documents compliance verification (e.g. product specific/trial specific ICF, protocol, CSR, IB, CRF etc.).
  • Involvement in QM CMRS audit CAPA management (tracking, oversight, follow-up).
  • Audit documentation management and maintenance (including audit logs).
  • Keep QM appraised of compliance and personnel issues through periodic reports.
  • Generate and provide metrics, status and other information in relation with GCP and GVP, as required by management.
  • Perform other duties as assigned, e.g. GCP and GVP training, support of Head QM CMRS, Head CQA Auditing and Head PV QA in Regulatory Authority inspection
  • Provide GCP and GVP training to staff as well as special training groups from business and sales
  • Write and contribute to the review of CMRS-related and corporate quality GSP/NSP procedural documents, as well as monitor and assess global safety and clinical processes and procedural documents for consistency and with global laws, regulatory requirements and Vifor Pharma policies and procedures
 
Minimum Requirements

  • Bachelor’s degree in health sciences, nursing, pharmacy or related field, Master’s degree preferred.
  • 6-8 years’ Clinical Quality Assurance
  • Minimum of 2 years’ experience in GCP and GVP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines (monitoring and/or drug safety or clinical operations experience are acceptable).
  • Experience in regulated environment, preferably pharmaceutical industry.
  • Ability to work independently and as part of global virtual team
  • This role involves minimum 20% travel.
  • Preferred requirements:
  • Flexibility, recognition of occasional unusual working hours due to international nature of operations.
  • Multilingual
  • User experience in TrackWise and other QMS tools/audit database systems.
 
Minimum Requirements

  • University degree
  • 6-8 years' Clinical Quality Assurance experience.
  • Minimum of 2 years’ experience in GCP and GVP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines (monitoring and/or drug safety or clinical operations experience are acceptable).
  • Experience in regulated environment, preferably pharmaceutical industry.
  • Ability to work independently and as part of global virtual team
  • This role involves minimum 20% travel.
Preferred Requirements:
  • University degree or equivalent in health sciences, nursing, pharmacy or related field.
  • Qualified at Master level.
Competencies:

  • Minimum requirements
  • High ethical standards and integrity.
  • Ability to work well independently and in a team environment, interact productively and effectively with peers, management and third parties.
  • Proficiency with MS Office including Word, Excel and PowerPoint.
  • Ability to maintain a high level of confidentiality.
  • Use resources effectively and reasonably.
  • Preferred requirements:
  • Excellent oral and written communication .
  • Strong interpersonal and organisational skills.
  • Flexibility, recognition of occasional unusual working hours due to international nature of operations.
  • Multilingual.
  • User experience in TrackWise and other QMS tools/audit database systems.
 
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Relypsa’s high regard for our employees.
 
NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
 
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

About Us

Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Companys first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com or check out our LinkedIn page.

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