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Full-Time

Sr Director Quality

Confirmed live in the last 24 hours

Pendulum

Pendulum

51-200 employees

Develops targeted probiotics for gut health

Biotechnology

Compensation Overview

$225.7k - $250.8kAnnually

+ Equity

Expert

San Francisco, CA, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • B.A./B.S. or M.S. in Biology/Biological Sciences, Food Science or related discipline. Ph.D. is a plus.
  • 15+ years industry experience in Quality. Working with food/dietary supplements is preferred. Experience with microorganisms is a plus.
  • Proven experience as Quality site head/leadership role, including establishing and growing a successful Quality function in a start-up environment.
  • Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA regulations and or guidance documents. Knowledge of international markets is a plus.
  • Excellent communication (written and verbal) and organizational/time management skills.
  • A demonstrated track record in the following key areas is required: Regulatory Agency and Certification (e.g. SQF, NSF, etc.) Inspection management. Collaboration and team building skills. High level of integrity and personal responsibility. Innovation and strategic thinking. Initiative and decision making. Identification and selection of eQMS.
  • Onsite position.
Responsibilities
  • Ensure cGMP compliance against 21 CFR Parts 117, 110, 101 and 11, as appropriate
  • Serve as subject matter expert (SME) and hold overall responsibility for implementation, direction and coordination of the QA, QC and Quality Systems functions; specifically: Quality on the floor, Raw material inspection and release, Disposition of product, Method validation, process validation, and equipment/utilities qualification, Laboratory and cross contamination controls, Internal auditing, Lead and manage regulatory and certification inspections, Quality event investigations and CAPA management, Change management and document/records management, Risk management, Data integrity, Quality metrics reporting/Management Review, Technology transfer, Stability program, Training program
  • Maintain 3rd party certifications as appropriate, eg. Safe Quality Food (SQF) and non-GMO certifications
  • Lead, assess, mentor and develop departmental associates and analysts. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members and train relative to responsibilities.
  • Establish Quality strategy, policies, define roles and problem solve. Collaborates with other Departmental Leaders on continuous improvement initiatives.
  • Key, pro-active contributor to long term strategic planning and part of leadership team.

Pendulum Therapeutics develops evidence-backed probiotics with targeted formulations of natural bacterial strains, including DNA-sequenced anaerobic strains rigorously tested and actively grown in their facility to mirror the conditions of the gut, providing novel solutions for gut health and metabolic optimization. The main technologies used in Pendulum's products include DNA sequencing, anaerobic strain cultivation, and targeted formulation of natural bacterial strains.

Company Stage

Series C

Total Funding

$121.4M

Headquarters

San Francisco, California

Founded

2012

Growth & Insights
Headcount

6 month growth

0%

1 year growth

17%

2 year growth

24%