Senior Manager/Associate Director, Clinical GCP Quality - Beam Therapeutics Cambridge, Massachusetts, United States Bookmark Share Print 36 0 0

Listing Description

Position Overview:


Beam is seeking a highly talented and motivated Senior Manager / Associate Director – Clinical GCP Quality to join our growing Quality team. The Senior Manager / Associate Director – Clinical GCP Quality will be responsible for – quality aspects of Beam’s clinical studies and overall Good Clinical Practice (GCP) as the company grows and continues to evolve from a research and discovery (R&D) company to a broader organization moving products though the clinical pipeline to commercial launch and growth. Reporting to the Senior Director – Clinical GCP Quality, this position will be a key member of Beam’s Quality organization, as well as clinical study team(s) working with Clinical Development functional-area leads to ensure appropriate levels of clinical compliance and quality. Additionally, this position may assist Non-clinical Development (NCD) and Clinical Bioanalytics & Translational Sciences (CBTS) colleagues with qualification activities of third-party laboratories.


Responsibilities:



  • Assist the Senior Director – Clinical GCP Quality in helping to define and drive the clinical compliance and quality vision and mindset within the company.

  • Continue to improve/refine Beam’s risk based GCP compliance program as the company moves from developmental phase to phase (i.e., R&D, clinical research pipeline, commercial launch, growth).

  • Ensure appropriate quality systems are in place to qualify clinical and non-clinical suppliers, which may include laboratories conducting regulated activities (clinical and non-clinical), clinical sites, and clinical study-related documents as they relate to GCP compliance.

  • Oversee clinical compliance and quality within the context of a clinical study team(s).

  • Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP.

  • Ensure appropriate escalation of significant issues that may impact patient safety, the reliability of clinical study results, product quality and/or supply, regulatory compliance, and/or company brand image.

  • May assist NCD and CBTS with qualification/requalification activities (questionnaires, audits, quality technical agreements, etc.).

  • May provide GxP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs).

  • May assist in preparation for health authority inspections at Beam, suppliers, and/or clinical sites.


Qualifications:



  • University degree in scientific discipline/life sciences OR equivalent experience in biotech or pharmaceutical industry.

  • 10+ years of relevant experience in a GCP (preferred) or related GxP environment with at least three years of demonstrated experience working with multi-disciplinary functional areas.

  • Solid knowledge of global regulatory requirements/standards for the pharmaceutical, biotech, or vaccine industry (experience in cell and/or gene therapies, a plus).

  • Positive approach.

  • Excellent interpersonal effectiveness and written/verbal listening/communication skills.

  • Excellent computer skills (quality and document management systems, clinical study-related systems (e.g., electronic data capture, interactive response technology, clinical trial management, etc.), and Microsoft products and services (e.g., Excel, PowerPoint, Visio, Word, etc.).

  • Highly attentive to details and able to work well as part of a team.

  • Demonstrates consistent quality, judgment, accuracy, speed, and creativity.

  • Takes initiative in making improvement suggestions to promote operational goals.

  • Applies quality concepts and company policies/standards to resolve issues of moderate complexity in an effective manner.

  • Facilitates designing processes with quality built in from the beginning.

  • Identifies and uses good judgment to handle out-of-compliance scenarios.

  • Ability to work independently.


Listing Details

  • Citizenship: Not Provided
  • Incentives: Not Provided

 

  • Education: Not Provided
  • Travel: Not Provided
  • Telework: Not Provided


About Us

AtmosJobs is a community-run job platform developed by SaaS professionals. Our unique approach of focusing strictly on Cloud positions allows us to personalize the user experience.

Our Contacts

1765 Greensboro Station Pl.
Suite 900
Tysons Corner Va 22102

(703) 594-7765