Job Description

Position Summary:
The QA Specialist for External Quality will be responsible, with management support, for providing oversight of
quality activities associated with drug substance, drug product and finished product manufacturing processes to
contract manufacturing organizations. The Specialist contributes and guides the completion of milestones
associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract
Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Acts independently
to determine methods and procedures on new assignments and provides guidance to lower-level personnel.
Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

Principal Responsibilities
• Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product
manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all
drug manufacturing, storage and shipping activities are compliant
• Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to
Drug Substance, Drug Product and Finished Product.
• Provides oversight to continuous quality system improvements and supports implementing improvements
at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as
they impact
• Works closely to build relationships with contract manufacturers quality personnel
• Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO
Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner
resulting from record reviews and deviation events
• Responsible for reviewing contractor documents i.e. Batch records, deviations and change controls to
ensure that they comply with procedures and meet the standards
• Approve specific standard operating procedures and controlled documents issued by contract
manufacturing organisations
• Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
• Develop and issue quality metrics pertaining to the process quality activities
• Trends and analyses quality aspects of technical transfer activities to measure key performance indicators,
identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses
at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
• Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis
investigations, tracking, follow-up and reporting/trending
• Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and
evaluating CAPA for effectiveness
• Represents Quality Assurance to guide various projects and technical meetings, as needed
• Responsible for documenting and reporting compliance issues to management
• Any other duties as required by management.
Note: This role requires 20% travel


Requirements

Qualifications:
• Must have experience/knowledge of drug substance, drug product and finished product manufacturing
processes in a cGMP environment
• Must have detailed knowledge of industry best practice and current regulatory expectations concerning
drug substance, drug product and finished product manufacturing. Minimum of 2-5 years' GMP related
experience in biopharmaceutical / pharmaceutical or related industry
• Experience working with contract manufacturing organisations
• Ability to provide project leadership and guide successful completion of Quality projects
• Excellent written and verbal communication and negotiating skills
• Risk assessment and risk management
• Ability to exercise judgment with defined procedures and practices to determine appropriate action
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of
established timelines in a fast-paced environment
• Ability to monitor and report on assigned tasks, goals, and objectives.

Education
• Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP
experience preferred; consideration will be given to other relevant experience and education.

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