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Sr Director Quality

Pendulum Therapeutics

Pendulum Therapeutics

Quality Assurance
San Francisco, CA, USA
Posted on Thursday, June 13, 2024
About Pendulum
Pendulum® is leading a revolution that is occurring around the world to improve physical and mental health by first understanding, then restoring and enhancing the human microbiome.
Studies have shown that our microbiome (the bacterial communities in and on our bodies) is linked to everything from metabolism and diabetes, to longevity, weight loss, healthy immune systems, cancer prevention, feelings of well-being, inflammatory bowel disease, and even healthy skin. We have just scratched the surface on understanding the impact that our microbiome has on our lives. During early life we develop a diverse and balanced microbiome that plays a critical role in shaping our long-term health. Over our lives, a combination of diet, lifestyle, antibiotics, and aging can decrease the effectiveness of our microbiome.
Pendulum recognized the enormous impact they could have on people’s lives if they were able to address the imbalances in the microbiome. To accomplish this, Pendulum created proprietary probiotic pipelines and a unique discovery platform to identify key, novel bacterial strains and the prebiotics that feed them. The company has also built and developed the world’s first manufacturing technology to produce bacteria in an anaerobic (oxygen-free) environment at scale.
The medical probiotics that Pendulum has formulated have transformed the consumer probiotics market into a new category of therapeutic offerings that deliver the power and efficacy of a pharmaceutical with the safety and accessibility of a natural probiotic. Due to Pendulum’s explosive revenue and customer growth over the last two years, the company earned a spot on Forbes Magazine’s exclusive “The Next Billion Dollar Startups” list.
If you’re interested in improving the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading.
Position Summary:
We are seeking a Senior Director to serve as Quality Site Head and lead Pendulum’s in-house quality team. The successful candidate will oversee and direct all Quality Unit functions (QA, QC and Quality Systems) and collaborate with internal business partners (including Manufacturing, Supply Chain, Process Development, Regulatory Affairs) to deliver the innovation pipeline and meet business targets. This position will be responsible for establishing the quality strategy into SOPs, tactical policies, processes and procedures to ensure compliance with all regulatory, company and customer requirements. Additional responsibilities include creating and managing departmental budget. The successful candidate will have strategic expertise and have strong, effective leadership skills to mentor the Quality team, while also maintaining a hands-on approach to further build the quality function at Pendulum. This role will report to the VP of Regulatory Affairs and Quality.

What You'll Do:

  • 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.

Knowledge 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

Salary & Benefits

  • $225,720-$250,800
  • Medical, Dental, and Vision
  • Commuter Benefits
  • Life & STD Insurance
  • Company match on 401 (k)
  • Flexible Time Off (FTO)
  • Equity