Director, Quality Assurance (Quality Systems)
The Director, Quality Assurance (Quality Systems) will be primarily responsible for the implementation and maintenance of Phase-appropriate Quality processes and procedures in accordance with Good Industry Practices (GXP) for Syncromune’s programs and products. The Director, QA (Quality Systems) will continue to build and cultivate GXP through organizational processes, including training programs and implementation and management of the electronic Quality Management System (eQMS) for the Drug division.
This role will serve as the primary interface and administrator for the Pharmaceutical Quality System (PQS) at Syncromune, with responsibility for establishing conformance to quality system requirements and ensuring system-level alignment with vendor, supplier, and CDMO quality activities. The role will lead the project team for the implementation of Syncromune’s electronic Quality Management System (eQMS).
Principal Duties and Responsibilities include the following:Lead administration and continuous improvement of Syncromune’s global Pharmaceutical Quality System (PQS), focusing on quality processes and infrastructure that support the company’s progression from startup to commercial operations. Enable compliant scalable growth across programs, sites and geographies in accordance with applicable regulations and standards.
Serve as Business Owner, Administrator, and Subject Matter Expert (SME) for the PQS and eQMS, including system level elements such as Document Control, Training, Deviation Management, Risk Management, CAPA, Change Management, Internal Audit, External Audit support, Vendor/Supplier Quality Systems Requirements, and the quality system components of Pharmacovigilance, Product Surveillance/ Complaints, and Recalls, while coordinating with Quality Management for operational and product-level activities.
Lead the evaluation, validation, implementation, and administration of an electronic Quality Management System (eQMS).
Manage the internal audit program.
Support and co-host GXP-focused audits, inspections, and assessments of Syncromune in partnership with Quality Management for auditors including, but not limited to:Notified Bodies
Regulatory Authorities
Customers
Potential partners
Partner with Supplier Quality Management, Drug Development, and other internal functions to ensure alignment between PQS requirements and external manufacturing quality activities, maintaining clear process ownership between system-level QA and operational QA.
Build and develop a high performing team to support and advance Syncromune’s business objectives.
Supervisory Responsibilities:Direct reports: to be defined as the team grows.
Qualification Requirements:
Education:Bachelor's degree in Life Sciences, Engineering, Medical Technology, or related scientific discipline required. Advanced degree preferred.
Professional certifications such as ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or other GXP certification a plus.
Experience:Approximately 10 years of progressively responsible experience in quality assurance within the pharmaceutical or biotechnology industry.
At least 5 years of experience in a leadership or management role of a PQS with direct report responsibilities.
Positive experience in hosting and managing regulatory authority inspections and completing remediation activities.
Demonstrated success in leading the implementation of an electronic Quality Management System (eQMS).
Knowledge/Skill:High degree of technology proficiency and fluency in Enterprise platforms.
Excellent project management skills with ability to manage multiple priorities in a fast-paced environment.
Commitment to integrity, ethics, and quality culture development.
Expertise in the US FDA Code of Federal Regulations and International Council on Harmonisation (ICH) as applicable to the pharmaceutical industry.
Exceptional leadership abilities with proven success building and motivating high-performing teams as well as turnaround teams.
Outstanding written and verbal communication skills with ability to influence at different functional and organizational levels both internally and with Vendor/ Contractor/ Supplier partners.
Demonstrated ability to work collaboratively across functions and across geographies, and skill in building effective partnerships for successful outcomes.
Proactive mindset, driving projects forward and providing recommendations to Leadership based on anticipated compliance challenges and industry trends.
Working Conditions:
Specify work environment:The work environment is remote, and must be in a suitable location that allows focused output and video meetings.
Domestic travel may be required up to 10% of time.
This role requires a high degree of computer screen time and the individual will be regularly required to see, talk, hear, read, and type.
Syncromune is an Equal Opportunity Employer.
Expected US salary range: $210,000-$230,000
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
This role will serve as the primary interface and administrator for the Pharmaceutical Quality System (PQS) at Syncromune, with responsibility for establishing conformance to quality system requirements and ensuring system-level alignment with vendor, supplier, and CDMO quality activities. The role will lead the project team for the implementation of Syncromune’s electronic Quality Management System (eQMS).
Principal Duties and Responsibilities include the following:Lead administration and continuous improvement of Syncromune’s global Pharmaceutical Quality System (PQS), focusing on quality processes and infrastructure that support the company’s progression from startup to commercial operations. Enable compliant scalable growth across programs, sites and geographies in accordance with applicable regulations and standards.
Serve as Business Owner, Administrator, and Subject Matter Expert (SME) for the PQS and eQMS, including system level elements such as Document Control, Training, Deviation Management, Risk Management, CAPA, Change Management, Internal Audit, External Audit support, Vendor/Supplier Quality Systems Requirements, and the quality system components of Pharmacovigilance, Product Surveillance/ Complaints, and Recalls, while coordinating with Quality Management for operational and product-level activities.
Lead the evaluation, validation, implementation, and administration of an electronic Quality Management System (eQMS).
Manage the internal audit program.
Support and co-host GXP-focused audits, inspections, and assessments of Syncromune in partnership with Quality Management for auditors including, but not limited to:Notified Bodies
Regulatory Authorities
Customers
Potential partners
Partner with Supplier Quality Management, Drug Development, and other internal functions to ensure alignment between PQS requirements and external manufacturing quality activities, maintaining clear process ownership between system-level QA and operational QA.
Build and develop a high performing team to support and advance Syncromune’s business objectives.
Supervisory Responsibilities:Direct reports: to be defined as the team grows.
Qualification Requirements:
Education:Bachelor's degree in Life Sciences, Engineering, Medical Technology, or related scientific discipline required. Advanced degree preferred.
Professional certifications such as ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or other GXP certification a plus.
Experience:Approximately 10 years of progressively responsible experience in quality assurance within the pharmaceutical or biotechnology industry.
At least 5 years of experience in a leadership or management role of a PQS with direct report responsibilities.
Positive experience in hosting and managing regulatory authority inspections and completing remediation activities.
Demonstrated success in leading the implementation of an electronic Quality Management System (eQMS).
Knowledge/Skill:High degree of technology proficiency and fluency in Enterprise platforms.
Excellent project management skills with ability to manage multiple priorities in a fast-paced environment.
Commitment to integrity, ethics, and quality culture development.
Expertise in the US FDA Code of Federal Regulations and International Council on Harmonisation (ICH) as applicable to the pharmaceutical industry.
Exceptional leadership abilities with proven success building and motivating high-performing teams as well as turnaround teams.
Outstanding written and verbal communication skills with ability to influence at different functional and organizational levels both internally and with Vendor/ Contractor/ Supplier partners.
Demonstrated ability to work collaboratively across functions and across geographies, and skill in building effective partnerships for successful outcomes.
Proactive mindset, driving projects forward and providing recommendations to Leadership based on anticipated compliance challenges and industry trends.
Working Conditions:
Specify work environment:The work environment is remote, and must be in a suitable location that allows focused output and video meetings.
Domestic travel may be required up to 10% of time.
This role requires a high degree of computer screen time and the individual will be regularly required to see, talk, hear, read, and type.
Syncromune is an Equal Opportunity Employer.
Expected US salary range: $210,000-$230,000
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.