Senior Specialist, External Quality

Position Summary:

The Senior Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations including technology transfers within the External manufacturing realm. The Senior Specialist contributes and supports 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. Performs’ all responsibilitiesin accordance withcompany policies, procedures, and regulations.

Principal Responsibilities: 

• Serving as Quality Assurance support and SME for Drug Substance, Drug Product andmaintainingknowledge 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.

• Providing oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as theyimpactAlexion

• Working closely to build relationships with contract manufacturers quality personnel

• Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issuesin a timely mannerresulting from record reviews and deviation events

• Reviewing contractor documents i.e., Batch records, deviations and change controls to ensure that theycomply withAlexion procedures and meet Alexion standards

• Approving Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organizations

• Supporting contract manufacturing organization audits, including pre-approval inspections

• Developing and issuing quality metricspertaining tothe process quality activities

• Reviewing and assessing deviations; includes performing risk assessments,participatingin root cause analysis investigations, tracking,follow-upand reporting/trending

• Reviewing Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness

• Supporting Quality Assurance to guide various projects and technical meetings, as needed

Qualifications:

• Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing. 

• Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry

• Experience working with contract manufacturing organizations.

• 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

• Experience workingwith gene therapy products preferred

Education:

• Bachelor’sdegreerequired. Advanced degreea plus.

Competencies:

• Excellent interpersonal skills arerequired, as is the ability to communicate well, both verbally and written. 

• High level technical skills including quality risk management,auditingand pharmaceutical manufacturing. Technical writing skillsrequired.