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Quality Director Quality / SR Director Quality - Onsite Bay Area , CA
ID: 23045

This individual will be involved in maintaining and improving the Quality Management System (QMS) through continuous development, implementation and maintenance of quality standards, policies and procedures, incorporating phase-based flexibility that ensures rigorous regulatory compliance. Additionally, he/she will be working closely with the internal cGMP manufacturing team to ensure compliance.

  • Performs gap assessment for Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Audits and Vendor Qualification.
  • Implements and maintains SOPs pertaining to Quality of GMP related activities.
  • Provides GMP training programs.
  • Provides mentorship to ensure compliance with relevant regulations.
  • Participates in internal and external audits for GMP activities.
  • Participates/Manages the auditing process and other QA inspectional activities.
  • Coordinates activities and interactions during regulatory agency inspections.
  • Identifies resource gaps and proposes solutions.
  • Adjudicates issues with compliance concerns.
  • Supports the Company's project teams and assists with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner
  • Other duties as assigned.

Compensation Details:

  • Orbis Clinical provides a reasonable range of compensation for this position. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
  • The Pay Range for this position is $180,000- $210,000. It is possible that this position can be hired outside of this salary range based on experience.

Fill out the form below to get in touch with our business development team, or call us at  (781) 328-1132.

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The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.