- Manages overall lot release process to ensure clinical requirements are met; Conducts record review of executed batch records for vector and drug product lots. 30%
- Opens deviations and investigations as appropriate based on Adaptimmune CMC and/or CMO notification; provides evidence of document closing at time of product disposition. 10%
- Assures all Quality events, change controls, CAPAs and/or other required documentation related to the product lots are initiated, assessed, reviewed, and approved prior to material/lot release. 15%
- Works with CMOS/CTLs to ensure timely delivery of documentation/materials. 10%
- Perform final quality review to release drug product for clinical use. 10%
- Participates in specification setting and approves final specifications for starting materials and final product; Evaluates analytical results against approved specifications to determine compliance; releases material for use and/or provides an appropriate disposition for products. 5%
- Develops process/procedures for release in conjunction with CMC personnel. 5%
- Evaluates lot test results against trending data to identify any irregular behaviour. 5%
- Establish key metrics for quality system monitoring ad process improvement, report at Quality Management Review5%
- Assists in the audits of contract manufacturers and contract laboratories for GMP compliance. 5%
- Support in the preparation for regulatory submissions and inspections, as needed.
- Bachelor's Degree in a scientific discipline.
- 7-10 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
- Direct experience managing CMO interactions.
- Solid technical writing skills related to investigation reports.
- Broad knowledge of GMP, ICH and FDA/EMA regulations
- Detailed knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
- Excellent writer including but not limited to SOPs and reports
- Proficiency using electronic document control systems and quality management systems.
- Experience conducting audits of contract manufacturing and laboratory organizations.
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Quality Assurance Manager - Cambridge, United States - Adaptimmune Therapeutics Plc
Description
Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations.
Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Our Quality team ensures the utmost quality and compliance across Adaptimmune and fosters an environment of partnership and collaboration where everyone is responsible for quality.
Ensuring everything is right the first time, every time is our mission.As a member of the Quality team, you become a part of a diverse and inclusive global organization which maintains quality oversight for every aspect of the manufacturing process from start to finish.
This includes, but is not limited to, raw materials, vector, supplier quality, audits and inspections, training, quality systems, quality operations, quality control, contract testing labs, and contract manufacturing organizations.
Come join a team where our patients are at the center of everything we do and where quality leads the wayPRIMARY RESPONSIBILITY
The Quality Assurance Manager, CMC, has responsibility for the overall management of batch record review and lot release.
He/she will be responsible for reviewing executed batch records, evaluating product deviations and drawing conclusions as to product disposition for material manufactured both internally by Adaptimmune and externally by contract manufacturers for Adaptimmune.
The successful candidate will work closely with Adaptimmune Quality Management, Quality Control, Manufacturing and External Contract Organizations to identify strategies, tactics and objectives for product quality and GMP compliance.
You will report to the Director of Quality Assurance and will have the opportunity to become a subject matter expert with leading edge technology while gaining valuable operational and partnership management skills.
This position is also a great opportunity to have a direct impact on patients.If you thrive in a highly collaborative, fast-paced environment and are looking for a role where you're given ownership and accountability to get results and make an impact, we want to hear from you.
KEY RESPONSIBILITIES
Required
We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category.
It is our intent that all qualified applicants will receive equal consideration for employment.#J-18808-Ljbffr
