Sr. Manager/Associate Director Clinical Quality Assurance - Gcp Vendor Oversight

Summary Description

The Sr. Manager/Associate Director, Clinical Quality Assurance - GCP Vendor Oversight will interface and build strong partnerships with other teams within Gossamer Bio and ensure appropriate qualification and oversight of clinical contract service providers throughout the lifecycle of our development programs.

This position reports to the Vice President, Clinical Quality Assurance and is located at our corporate headquarters in San Diego, California.  The position may be remote based depending upon the candidate.

Essential Duties and Responsibilities:

• Manage vendor qualification efforts across Gossamer Bio, working closely with subject matter experts in GCP, GVP, and GLP areas. Support GMP and GDP vendor qualifications as needed.
• Partner with business process stakeholders to evaluate vendors using a risk-based and phase appropriate model.
• Schedule third party GCP vendors for initial qualification or requalification based on criticality, compliance history, as well as future business plans.
• Oversee the conduct of vendor audits, internal process audits and mock inspection preparation activities as per the approved schedule. Supervise consultant auditors and conduct audits as applicable.
• Manage the review and negotiation of CRO Quality Agreements on behalf of Gossamer Bio
• Drive Risk Mitigation and Continuous Improvement initiatives by partnering with functional stakeholders to reduce risk in an iterative fashion.
• Leverage risk mitigating actions to drive cultural enabling change.
• Support the management of regulatory inspections, both as a support team leader and a Subject Matter Expert, during on-site and virtual/remote evaluations.
• Train new auditors on investigation techniques, technical aspects, and relationship management.
• Enhance policies and procedures and ensure compliance with applicable regulations.
• Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
• Ensure correct resource allocation of internal and external Vendor Management resources to projects and continuous improvement initiatives.
• Create and drive improvement in key performance metrics reportable to Quality management.

Job Qualifications:

• Bachelor's degree in a life science field
• 6+ years of related Quality Assurance or Compliance experience in the pharmaceutical or biopharmaceutical industry.
• Extensive experience leading clinical vendor audits across several GCP areas (e.g., monitoring, data management, central laboratories).
• Experience managing a GCP vendor audit schedule, planning for individual audits, and following corrective/preventive actions to complete resolution.
• Strong working knowledge of regulations and industry best practices, including GCP, GCLP, and GVP areas.
• Experience with applicable phases of the product development lifecycle (early stage clinical through commercial).
• Knowledge of 21 CFR Part 11, data integrity, and computer system validation best practices.
• Certification as a Qualified Auditor by an established industry organization.
• Experience supporting regulatory inspections and audits.

• Demonstrated ability to apply risk-based approaches to achieve a phase appropriate and fit-for-purpose outcome.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Must possess excellent communication and presentation skills, relationship-building capabilities, and a proven ability to influence decision-making without authority.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excitement about the vision and mission of Gossamer Bio.
• Ability to travel to Gossamer Bio corporate offices and third-party vendor locations, up to 25%.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

For California based applicants, the expected salary range for this position is $150,000 to $170,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/