Aug 18, 2021

Quality Manager / Engineer

  • X-Therma Inc.
  • Richmond, CA, USA
Full time Biotech Quality

Job Description

About X-Therma:

X-Therma pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need. Our vision is to enable Global organ exchange to save millions of lives. We appreciate talented, driven, and fearless individuals looking to make a positive impact for the World. We are located in the San Francisco East Bay, not only known for its beautiful scenery and comfortable weather all year round, but also you can truly embrace the breadth of innovation and dream building spirit of San Francisco.

Quality Manager / Engineer

X-Therma is seeking a highly motivated Quality Assurance professional. You will have a great opportunity to contribute to groundbreaking, life-saving products through the full product development cycle. The Quality Assurance Manager is responsible for driving the quality systems and quality operations of the Company. The applicant will have close interactions with the executive team and others at all levels. This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities. Important for this role is a deep set of knowledge in all aspects of quality and how quality relates to the performance of an organization.

Highly interested applicants are encouraged to submit a specific cover letter with your resume.

Principal Responsibilities:

  • Develops and implements documentation control function including preparation and distribution of operating procedures, batch production records, lot packages, maintenance of historical files and master records, and issuance of batch records and procedures manuals. Develops, updates, reviews and approves SOP’s to conform to company and federal regulations.
  • Recommends and develops a compliance strategy for management on GMP matters and regulatory compliance posture of the individual departments
  • Reviews process, raw material, equipment changes and deviations to determine the impact on product quality and acceptability. Approves all changes and determines the quantity and types of testing required to assure acceptability of product thus meeting regulatory requirements and SB standards.
  • Manages compliance activities including the compilation of annual report information for all products and for the filing/finishing operations at X-Therma, updating DMF’s, DEA activities and PDMA activities. Coordinates efforts to assure all mandatory licenses and registrations are kept current and in compliance with Federal and State Requirements.
  • Responsible for reviewing and approving all proposed technical changes via Change Control System, having a potential impact on PLA’s and ELA’s to determine the type of notification, if any, to FDA. Responsible for obtaining approvals per corporate procedures for proposed changes impacting PLA and ELA, and preparing dossiers for submission.
  • Coordinates, performs, evaluates and reports findings and follow-up activities of routine audits. Provides each audited area with the support and guidance to undertake necessary corrective actions. Maintains a follow-up system to assure that required improvements and programs are being carried out as planned.
  • Develops and implements the training/education function including development and administration of training activities relating to cGMPs, departmental operating procedures and statistical process control programs, developing in-house programs, maintaining audio/visual inventories and maintaining training records.
  • Interprets all applicable regulations and associated guidelines dealing with such matters for the company. Keeps informed on trends and developments in the field of GMP regulations and on industry practices of compliance.
  • Directs the daily Product Assurance functions; product inspection, record review and release to stock for the finished product. Examines and evaluates investigation reports and dispositions of raw materials, intermediates and finished products. Reviews ongoing records for completeness, accuracy and compliance; manages a collection of reserve and laboratory samples of finished products.
  • Determines the acceptability of materials where deviations have occurred. After reviewing all technical aspects including Investigation Reports and GMP information determines what further information is needed for the disposition of the material to be determined. Routinely responsible for releasing materials.
  • Develops objectives, educates personnel in compliance, develops, and implements GMP Audit Program for all operating areas

Required experience and skillset:

  • MS in a relevant technical discipline.
  • 4-6+ years of industrial experience in quality organizations, either in operations or assurance functions.
  • 3+ years leading quality assurance (compliance and /or product release) within the clinical or commercial organization.
  • Fully versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, and compliance.
  • Strong process and detail orientation.
  • Flexible mindset able to solve and anticipated problems.
  • Prior responsibility for technical SOPs, Batch Production Records (BPR) and technical reports.
  • Prior demonstrated experience in determining acceptable quality metrics of an API or similar product.
  • Proven strategic planning skills for the management of long-term projects that lead to success.
  • Ability to adapt and respond quickly to change in a dynamic, high-growth environment and radiate a positive impact on the team.
  • Thrive in an early stage environment with a proactive attitude; no task is too big or too small for you.
  • A strong work ethic to deliver results within the timeline.
  • Strong analytical and problem-solving skills, organization skills and attention to detail.
  • Must be able to work in an office setting without prohibitive limitations.

Additional Details:

Every individual at X-Therma has a direct impact on our collective mission to improve access to organ transplantation worldwide and save millions of lives. It is part of X-Therma's values to satisfy your personal development goals to become better every day.

Our competitive package includes:

  • Competitive base salary
  • Health, Vision and dental benefits
  • Paid, vacation, sick, holiday
  • 401(k) savings plan
  • Employee Stock Option Plan
  • The safe work environment for COVID response and high-quality PPEs.
  • And more!

X-Therma is an Equal Opportunity Employer. X-Therma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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