Rhythm Pharmaceuticals Sr Director, GMP Quality (Head of GMP Quality) in Boston, Massachusetts
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that?s passionate about transforming the lives of people living with rare genetic disorders of obesity. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Rhythm seeks an experienced and highly motivated individual to join its team in Boston, Massachusetts. The incumbent will be responsible for oversight of the GMP Quality department supporting product development, clinical/commercial manufacturing and analytical activities, technical development of personnel and ensuring quality.
Recognized for technical expertise both within and outside of the organization and is responsible for development and maintenance of relationships with CMO Quality organizations.
Responsibilities and DutiesLead the GMP Quality with primary responsible with providing quality oversight and support to all product development programs
Support of external manufacturing at CMOs across all phases of development for starting material, drug substance, drug product intermediates, and drug product.
Responsible for clinical and commercial batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
Lead GMP Quality supporting analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports.
Negotiate, monitor and maintain Quality Agreements with CMOs and Contract labs
Ensure CMO oversight is performed and is monitored for continuous improvement.
Performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Leads MRB as needed.
Assesses and approves change controls, CAPAs, SOPs and ensures regulatory submissions align with filing strategy.
Develop Quality Metrics to support system and process improvement activities
Leads and manages complex projects/teams within corporate objectives and project timelines
Participates in cross-functional projects in Quality expert and leader role
Qualifications and Skills
Undergraduate degree (advance degree preferred) with 10 +years of relevant industry work experience
Broad knowledge of GMPs including global expectations
Strong leadership skills, ability to lead and manage projects/teams within corporate objectives and project timelines
Proficient in utilizing project management processes, tools to lead meetings, assist with project planning, and facilitate completion of tasks
Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approach
Experience working on peptides, small molecules, and combo products.
Proven experience in managing outsourced GMP works in a virtual environment.
Expert knowledge of global GMP requirements governing raw materials, drug substance, and drug products
Root Cause Analysis tools/methodology and ability to act quickly with transparency
Ability to drive results on time, maintain composure under pressure, take ownership and accountability for shared information
Knowledge of applications, such as: Veeva, MS Office, etc.
This role is based in our Corporate office in Boson, Massachusetts. Candidates applying must be willing and able to be in the Boston office once it is safe to do so, per State and Federal COVID-19 guidelines.
More about Rhythm
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm?s mission is to improve the understanding of these disorders and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company?s clinical development program is currently focused on several rare genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, please visit www.UNcommonObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.