Head of Quality Assurance, GxP bei Merida Biosciences

Description

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.

Responsibilities 

• Develop, implement, maintain, and effectively communicate the Company's Quality Management Program. Provide leadership and strategic guidance in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of Company operations, processes, and products.
• Ensure the Company is current with all new quality-related regulatory requirements, and provide guidance to senior and operational management on the implications of any new or updated requirements.
• Maintain a fit for purpose quality management system (QMS) across the GxPs by directing and providing oversight and input into the relevant quality systems and standards including but not limited to: change control; documentation systems; quality procedures, standards, and policies; product complaints; quality system reporting; personnel training documentation and other related areas.
• Ensure the QMS has the appropriate level of rigor and controls to ensure compliance with applicable regulations and guidance. Create and execute a plan for ensuring a state of inspection readiness and continuous improvement including:
  • Maintain an inspection-ready environment at all times through a robust, internal self audit program and delivery of audit-readiness functional training;
  • Ensures the follow-up and closure of all corrective and preventive actions (CAPAs) from internal audits, regulatory health authority inspections and notified third-party audits Create a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues.
• Ensure rapid escalation of significant quality issues or concerns. Ensure the completion of scheduled third-party audits by internal QA staff or external contractors. Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution; provide suitable recommendations and facilitate ongoing quality improvements while maintaining compliance.
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained; ensure the development and maintenance of GMP/GLP/GCP.

Requirements

• Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus. Minimum 10 years of Quality leadership experience
• Experience implementing quality and business process improvement initiatives in an emerging biotech environment. 
• Strong analytical and problem-solving skills possessing proven record on quality tools.
• Prefer hands-on experience implementing Quality initiatives across the company
• Experience in all phases of regulatory submissions and interactions; international health authority experience desired. 
• Experience with documentation systems and with document review and auditing. 
• Excellent communication skills, team members that can work collaboratively with colleagues across all functions.
• Excellent analytical, presentation, writing, and computer skills are required.
• Comprehensive knowledge of current US and ex-US quality related regulatory guidelines.
• Demonstrate excellent leadership and communication skills.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Experience handling health authority inspections required; Experience in overseeing or participating in GxP audits; experience including external CRO, clinical/regulatory and document auditing desirable.

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.