About Pendulum
Pendulum® is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics™ (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration.
Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them.
We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success.
If you’re interested in building a new category of products that will help improve 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:
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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
- 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:
- 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:
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- 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
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- $225,720-$250,800
- Medical, Dental, and Vision
- Commuter Benefits
- Life & STD Insurance
- Company match on 401 (k)
- Flexible Time Off (FTO)
- Equity
