Location: all cities,AK, USA
Who we are: Agios 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 rare diseases – and make a bigger difference in their lives. In the U.S., Agios 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, Agios 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: Agios Pharmaceuticals is searching for a dynamic Manager, Clinical Development Compliance to join our team. The Manager, Clinical Development Compliance will provide oversight of GCP activities executed within the Clinical Development group including studies, programs, and processes. They will contribute to and help support Clinical Development audit / inspection planning, management, and response generation. The Manager, Clinical Development Compliance is responsible for driving a culture of quality and will serve as an advocate for the Quality Management System (QMS) in collaboration with the Agios QA group. They will act as the functional quality representative and will provide leadership and expertise for investigations of potential or actual quality issues pertaining to GCP and will escalate as necessary to QA and functional Department Heads. In consultation with GCP stakeholders, she/he will determine the overall risk for quality issues in collaboration with the QA team and will facilitate the development and execution of CAPAs as required, including the evaluation of the adequacy of the CAPAs / Effectiveness Checks. Additionally, she/he will contribute to or lead study risk oversight and assessments, provide guidance to establish measures that reduce compliance risks and be actively involved in pro-active inspection readiness activities. What you will do: Drives development and implementation of Clinical Development Quality Risk Management activities across the portfolio in collaboration; develop risk oversight strategy across portfolio Reviews global GCP guidance/regulations, industry best practices, Agios policies and procedures and interprets into Clinical Development functional level process updates and improvements Serves as a centralized point of contact working with all Clinical Development staff to support the creation, review, approval, and management of all department process deviations and CAPAs. Drives compliance, completeness, and timely closure. Reviews and assesses Clinical Development controlled documents for possible gaps with respect to quality, compliance, and regulatory commitments. Oversees Clinical Development compliance with controlled document review cycles. Participates in process improvements and functional initiatives, as required, as a lead reviewer to ensure compliance with ICH GCP Implements Clinical Development process compliance reviews as needed. Monitors functional metrics to assess compliance with processes and procedures and evaluate for potential quality signals / trends. Engages with process owners, subject matter experts, and functional area leads to create, implement, and review quality and compliance risks, and proposed solutions. Provides consultation on quality questions / issues for programs and studies. Acts as quality liaison with vendor quality representatives as needed. Contributes to the development of audit responses in collaboration with QA and cross-functional team members Supports site and sponsor inspection preparation for Clinical Development, identifying key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate. Leads functional level investigation and Root Cause Analysis of quality issues. What you bring: Bachelors Degree 4 years' experience in clinical operations or data management or quality function or equivalent In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives, as examples) Strong experience in supporting GCP and regulatory clinical trial inspections as a functional quality representative. Understanding of quality by design, risk assessments, risk oversight, quality measures and metrics Excellent written and verbal communication skills, including strong ability to facilitate meetings / discussions and influencing without direct authority. Ability to manage change and lead in an evolving organization. Ability to analyze and assess GCP Compliance risks and articulate potential Clinical Development business impact. Critical thinking, judgment, and decision-making skills Work Location: Location Agnostic: Work location for this role is based on employees 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.