Full-Time

Sr Director Quality

Posted on 6/27/2024

Pendulum

Pendulum

11-50 employees

Healthcare risk management consulting services

Consulting
Enterprise Software
Healthcare

Compensation Overview

$225.7k - $250.8kAnnually

Senior

San Francisco, CA, USA

Onsite position.

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 specializes in risk management consulting for the healthcare industry, focusing on reducing professional liability exposure for various healthcare operations such as hospitals, aging services, and home health. The company offers a web-based enterprise risk management tool that assists organizations in optimizing their risk management strategies. Their services include risk control assessments, training, and desk-based consulting provided by experienced consultants. Unlike many competitors, Pendulum combines specialized consulting with data-driven reports and web-based tools tailored specifically for healthcare providers. The goal of Pendulum is to help healthcare organizations effectively manage and mitigate risks, ensuring safer operations and better patient care.

Company Stage

Series B

Total Funding

$34M

Headquarters

Albuquerque, New Mexico

Founded

2012

Growth & Insights
Headcount

6 month growth

4%

1 year growth

4%

2 year growth

4%
Simplify Jobs

Simplify's Take

What believers are saying

  • Personalized nutrition trend aligns with Pendulum's microbiome science focus.
  • Global probiotics market growth benefits Pendulum's product offerings.
  • BRP Group acquisition provides resources to expand Pendulum's market reach.

What critics are saying

  • Increased competition from Seres and Finch in microbiome therapeutics.
  • Patent approval delays could affect Pendulum's pending patents.
  • Regulatory scrutiny on probiotics may impact Pendulum's product approvals.

What makes Pendulum unique

  • Pendulum Therapeutics leverages microbiome science and DNA sequencing for innovative therapies.
  • Pendulum Glucose Control is a clinically proven probiotic for blood sugar management.
  • Pendulum offers specialized risk management consulting for diverse healthcare operations.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Company Match

Flexible Work Hours

Equity

Commuter Benefits

INACTIVE