Job Description

Who we are:
This is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., the company markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, the company is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.  
The impact you will make:
This company is searching for a dynamic Manager GMP QA – Clinical to join our growing QA team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Manager GMP QA Clinical will be responsible for supporting and maintaining high quality levels on Drug Substance, Drug Product, packaged Drug Products and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional must possess strong leadership skills in order to provide support to the QA Clinical team, and will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities.  This role will report to the Associate Director, GMP Quality Assurance and be a member of the GMP clinical group.

What you will do:

• Conduct product release activities mainly for packaged drug product and finished goods for all phases of development including review and approval of master batch records and executed batch records.
• Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.
• Coordinate QP release as appropriate.
• Work collaboratively with key stakeholders on drug packaging/labeling strategies and plans to ensure investigational product releases within timelines.  Organize and coordinate QA operational packaging and labeling resources and schedule. 
• Effectively interact with external contract packagers/labelers and ID testing laboratories as well as work as part of an internal multidisciplinary team to support packaging/labeling, testing, and product complaint investigations.
• Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.
• Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to conduct, review and approve manufacturing, testing, and product complaint investigations.
• Assist in preparing or reviewing CMC sections of regulatory submissions.
• Manage and address associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
• Implement necessary Quality Agreements.
• Represent the QA department on project teams.
• Conduct audits of CMOs, Testing Laboratories, or any other services such as labels, etc.

What you bring:

• Bachelor’s degree in biology, chemistry, life sciences or a related field.
• Minimum 5 years’ experience of Quality Assurance experience in a cGMP manufacturing environment.  Experience related to global clinical packaging and labeling is a plus.  
• Strong attention to detail, and quality of work skills is a plus. 
• Excellent time management skills with a proven ability to meet deadline.
• Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, clinical operations and handling quality reports and documentation.
• Exercises judgment within broadly defined practices and policies in determining solutions and actions.
• Demonstrates ability to identify and recognize critical decisions that will result in delays in schedule or operations that may jeopardize overall business activities.
• Knowledge of drug substance, drug product and solid dosage manufacturing principles, equipment, and processes.
• Proficiency using Office 365, electronic document system (Veeva), Smartsheet, electronic inventory system and Adobe Acrobat.

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package . We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Job Tags

Remote job, Contract work, Temporary work, For contractors, Flexible hours, 3 days per week,

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