On Demand Pharmaceuticals, Inc.
Head of Quality Operations
On Demand Pharmaceuticals, Inc., Rockville, Maryland, us, 20849
On Demand Pharmaceuticals (ODP) (www.ondemandpharma.com) is changing the way we make and distribute medicines—by providing them to anyone, anywhere, anytime. ODP is creating innovative manufacturing platforms to enable our vision to produce critical medicines at the point of care and to secure the pharmaceutical supply chain. ODP is seeking a head of Quality Operations to support our expanding efforts and scaling our solutions.
Background
The Head of Quality Operations will report directly to the Chief Medical Officer. This role will work closely with cross-functional teams including Manufacturing, Pharmacy, Validation, Regulatory, and Quality Control Operations as well as supervise contractors to help ODP achieve its organizational objectives and ensure the consistent production of high-quality pharmaceutical products. The role may include up to 20% travel. The specific scope of work is listed below:
Quality Management Systems:
Lead quality management system (QMS) development, implementation, and continuous improvement to US and international regulations and standards, including compliance to cGMP, US 21 CFR Part 210, 211, 11, and ISO 13485:2016.
Establish and maintain a robust quality culture across ODP, driving adherence to regulatory requirements and industry best practices.
Manage the internal and external audit programs, ensuring readiness for regulatory agency inspections, including FDA and other global regulatory bodies.
Oversee the development and execution of a comprehensive training program for all quality-related activities, ensuring that staff are adequately trained on QMS processes, SOPs, and regulatory requirements.
Quality Assurance:
Ensure effective Document Control and Change Control processes, including review and approval of all relevant documents such as manufacturing batch records, SOPs, protocols, and quality policies.
Lead the supplier qualification program, including evaluation, auditing, and ongoing monitoring of suppliers to ensure compliance with quality standards.
Manage the quarantine and release of raw materials, consumables, and other critical components, ensuring that only approved materials are used in production.
Oversee Environmental Monitoring programs at both headquarters and point-of-care facilities, ensuring compliance with regulatory requirements.
Ensure compliance to the site's data integrity policy and principles of ALCOA+ for all relevant employees.
Compliance and Risk Management:
Facilitate the generation, review, and approval of Change Controls (CCs), Deviations (DEVs), and Corrective and Preventive Actions (CAPAs) within the Veeva system.
Lead the preparation for regulatory audits and inspections, including conducting mock audits, gap assessments, and implementing corrective actions as needed.
Monitor compliance with all relevant regulatory requirements, ensuring that the ODP remains audit-ready at all times.
Validation and Qualification:
Review and approve validation lifecycle documentation, including equipment qualification, computer systems validation, process validation, cleaning validation, and related protocols, risk assessments, reports and discrepancies.
Oversee the preparation, review, and approval of the Validation Master Plan (VMP) for headquarters and point-of-care facilities, ensuring alignment with regulatory expectations.
Ensure that all validation activities are conducted in accordance with established protocols and that any deviations are properly documented and addressed.
Documentation and Records Management:
Oversee the archival and management of paper records, including QC testing results, logbooks, technical operating procedures (TOPs), and other critical documentation.
Manage the process for transitioning documents from draft to effective status, ensuring that all records are accurately processed and readily available for review.
Coordinate the printing, binding, and distribution of protocols and other key documents for execution by the relevant teams.
Leadership and Team Development:
Build and lead a high-performing Quality Operations team, providing mentorship, guidance, and professional development opportunities.
Foster a collaborative and results-oriented work environment, encouraging cross-functional teamwork and open communication.
Serve as a key member of the senior leadership team, contributing to strategic decision-making and long-term planning for the organization.
Qualifications:
Bachelor’s degree in a related scientific discipline (e.g., Chemistry, Pharmacy, Engineering) required; advanced degree preferred.
Minimum of 5 years of experience in Quality Assurance or Quality Operations within the pharmaceutical industry.
In-depth knowledge of cGMP, US FDA regulations (21 CFR Part 210, 211, 11).
Proven experience in leading regulatory inspections and audits, with a successful track record of maintaining compliance.
Strong understanding of quality systems, validation processes, and risk management in a pharmaceutical manufacturing environment.
Excellent leadership, communication, and organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
Preferred Skills:
Experience with electronic quality management systems (eQMS), particularly Veeva.
Certification in quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer).
Experience in generic drug manufacturing and knowledge of regulatory pathways for generic products in the U.S. market.
Job Type: Full-time
Pay: From $140,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Ability to Commute:
Rockville, MD 20850 (Required)
Ability to Relocate:
Rockville, MD 20850: Relocate before starting work (Required)
Work Location: In person
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Background
The Head of Quality Operations will report directly to the Chief Medical Officer. This role will work closely with cross-functional teams including Manufacturing, Pharmacy, Validation, Regulatory, and Quality Control Operations as well as supervise contractors to help ODP achieve its organizational objectives and ensure the consistent production of high-quality pharmaceutical products. The role may include up to 20% travel. The specific scope of work is listed below:
Quality Management Systems:
Lead quality management system (QMS) development, implementation, and continuous improvement to US and international regulations and standards, including compliance to cGMP, US 21 CFR Part 210, 211, 11, and ISO 13485:2016.
Establish and maintain a robust quality culture across ODP, driving adherence to regulatory requirements and industry best practices.
Manage the internal and external audit programs, ensuring readiness for regulatory agency inspections, including FDA and other global regulatory bodies.
Oversee the development and execution of a comprehensive training program for all quality-related activities, ensuring that staff are adequately trained on QMS processes, SOPs, and regulatory requirements.
Quality Assurance:
Ensure effective Document Control and Change Control processes, including review and approval of all relevant documents such as manufacturing batch records, SOPs, protocols, and quality policies.
Lead the supplier qualification program, including evaluation, auditing, and ongoing monitoring of suppliers to ensure compliance with quality standards.
Manage the quarantine and release of raw materials, consumables, and other critical components, ensuring that only approved materials are used in production.
Oversee Environmental Monitoring programs at both headquarters and point-of-care facilities, ensuring compliance with regulatory requirements.
Ensure compliance to the site's data integrity policy and principles of ALCOA+ for all relevant employees.
Compliance and Risk Management:
Facilitate the generation, review, and approval of Change Controls (CCs), Deviations (DEVs), and Corrective and Preventive Actions (CAPAs) within the Veeva system.
Lead the preparation for regulatory audits and inspections, including conducting mock audits, gap assessments, and implementing corrective actions as needed.
Monitor compliance with all relevant regulatory requirements, ensuring that the ODP remains audit-ready at all times.
Validation and Qualification:
Review and approve validation lifecycle documentation, including equipment qualification, computer systems validation, process validation, cleaning validation, and related protocols, risk assessments, reports and discrepancies.
Oversee the preparation, review, and approval of the Validation Master Plan (VMP) for headquarters and point-of-care facilities, ensuring alignment with regulatory expectations.
Ensure that all validation activities are conducted in accordance with established protocols and that any deviations are properly documented and addressed.
Documentation and Records Management:
Oversee the archival and management of paper records, including QC testing results, logbooks, technical operating procedures (TOPs), and other critical documentation.
Manage the process for transitioning documents from draft to effective status, ensuring that all records are accurately processed and readily available for review.
Coordinate the printing, binding, and distribution of protocols and other key documents for execution by the relevant teams.
Leadership and Team Development:
Build and lead a high-performing Quality Operations team, providing mentorship, guidance, and professional development opportunities.
Foster a collaborative and results-oriented work environment, encouraging cross-functional teamwork and open communication.
Serve as a key member of the senior leadership team, contributing to strategic decision-making and long-term planning for the organization.
Qualifications:
Bachelor’s degree in a related scientific discipline (e.g., Chemistry, Pharmacy, Engineering) required; advanced degree preferred.
Minimum of 5 years of experience in Quality Assurance or Quality Operations within the pharmaceutical industry.
In-depth knowledge of cGMP, US FDA regulations (21 CFR Part 210, 211, 11).
Proven experience in leading regulatory inspections and audits, with a successful track record of maintaining compliance.
Strong understanding of quality systems, validation processes, and risk management in a pharmaceutical manufacturing environment.
Excellent leadership, communication, and organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
Preferred Skills:
Experience with electronic quality management systems (eQMS), particularly Veeva.
Certification in quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer).
Experience in generic drug manufacturing and knowledge of regulatory pathways for generic products in the U.S. market.
Job Type: Full-time
Pay: From $140,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Ability to Commute:
Rockville, MD 20850 (Required)
Ability to Relocate:
Rockville, MD 20850: Relocate before starting work (Required)
Work Location: In person
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