Manager, Quality Operations
About Clade Therapeutics
Clade Therapeutics is a well-funded, early-stage cell therapy company developing novel cell-based medicines for the treatment of cancer and other devastating diseases. The company was recently founded by an exceptional group of academic leaders and successful bioentrepreneurs. The Company works at the convergence of stem cell biology, immunology, regenerative medicine, and gene editing to create the next-generation of stem cell-derived medicines.
We are passionate about delivering on the promise of cellular therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients.
Position Summary
We are seeking a Manager, Quality Operations to provide quality expertise to support our Quality team for the development and commercialization of Clade’s products in compliance with relevant US, EU and ICH requirements. The Manager, Quality Operations role will support in development and continuous improvement of clinical Drug Product disposition for intermediate, drug substance and drug product manufactured and tested internally and externally. The main responsibilities of this job will be supporting and overseeing resolution of quality issues encountered with cGMP drug product manufacturing, working and master cell bank manufacturing, cell line editing, lot release testing, and raw material management. Operational support is also provided to our teams responsible for facility management, equipment, validation, and sample management.
Operational support is also provided to our teams responsible for facility management, equipment, validation, and sample management.
This position will report to the Associate Director, Quality Assurance and will be located in the Boston, MA office with additional onsite support needed at our partnering cleanroom facility/facilities.
Responsibilities
- Responsible for clinical batch disposition, review, and quality oversight of CMOs. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing, temperature excursions, and other quality systems as applicable to determine acceptability of product disposition.
- Responsible for review/approval of clinical lot COAs, generating BSE/TSE statement and product labelling as applicable.
- Review and approve documents including master batch records, qualification protocols and reports, lab investigations, retest plans, quality issues/deviations, CAPAs, supporting trend analyses, and change controls.
- Responsible for archival of batch records and other supporting documents in eDMS.
- On-the-floor support of Manufacturing activities during times of production.
- Assist with the development and implementation of Quality Operations SOPs, Work Instructions, training materials and reference guides.
- Provide subject matter expertise to assure Quality Issues/Deviations, Investigations/RCA, CAPA, Effectiveness Checks, and Change Controls to meet current regulatory requirements and industry practices including preparation and review of documentation.
- Lead risk assessment initiatives in close collaboration with internal and external interfaces.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner to continuously assess and improve processes.
- Liaise with key stakeholders to ensure only approve vendors are used in support of GxP operations.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Perform other duties as assigned.
Qualifications
- Bachelor’s degree in Computer Science, Life Science or related field.
- 6-8 years in Quality Assurance experience in the life sciences industry including GMP, GLP, GCP, GTP environments, ideally all phases of clinical development to commercial drug product.
- Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
- Knowledge of cGMP Regulations for Ph I – III clinical trials (FDA & International)
- Experience in reviewing batch records, product disposition and product labelling.
- Experience in supporting laboratory investigations, risk assessments, root cause analysis, CAPAs.
- Experience in interactions with Contract Manufacturing Organizations.
- Experience with cGMP auditing.
- Demonstrated success in collaborating with cross functional teams.
- Experience in gene/cellular therapies preferred.
- Laboratory experience preferred.
- Strong software proficiency with Microsoft Suite and other desktop applications, experience using Veeva Vault would be desired.
- Ability to manage multiple projects in a dynamic environment with attention to detail.
- Well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
- Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
Corporate Values
- Patients First – Proactively and constructively engage to deliver results for those in need. “Begin with patient’s success in mind”
- Communication and Respect – Foster open exchange with colleagues and collaborators. Seek to understand and treat people with courtesy. “Better together”
- Integrity & Excellence – Act honestly and ethically to seek the truth. Courageously doing the right thing – take smart risks and make tough decisions in pursuit of exceptional outcomes. “Get it done right”
Clade Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, gender, age, religion, national origin, disability, veteran status, sexual orientation or any characteristic protected under applicable law.