Senior Manager, GCP QA (Program Lead)
Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information.
The Senior Manager, QA will oversee GCP clinical compliance programs. This manager will be responsible for ensuring that associated external and internal entities meet all regulatory requirements.
Summary of Key Responsibilities
Act as GCP QA Program Lead while working with internal customers to ensure overall compliance from risk-based principles.
Act as expert GCP consultant to groups within the Alnylam organization.
Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.
Work with internal and external GCP customers and develop and execute strategic audit plans.
Support the development and/or review of audit agendas, audit reports, and CAPA's for internal & external audits.
Support the development, implementation and maintenance QA systems and SOPs for GCP systems.
Act as a contact with members of Regulatory Authorities and / or vendors; help lead inspections / audits, in agreement with QA management.
Participate in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
Participate in budget forecasting, planning and tracking for QA.
Maintain relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact Alnylam's SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable.
Travel on assignment, average of 25-40%.
Other assignments as directed by the Quality Assurance management team.
Educated to degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. Master's degree in a science, technology or industry related discipline, preferred.
At least 4 years' experience in GCP Quality that support pharmaceutical development.
Extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing.
Expertise in GCP regulations and guidance for FDA and International agencies including ICH guidelines.
Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions.
Experience with Microsoft based applications and ability to learn internal computer systems.
Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork.
Ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
Diplomatically address sensitive issues confidentially and professionally.
Excellent knowledge of, and working experience with, relevant national / international regulations.
Provide leadership to teams and projects to aid in successful conclusion.
Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
Ability to identify quality issues/discrepancies, and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
Demonstrate good judgment and decision-making experience.
Work professionally with highly confidential information.
Work independently and within a team.
Ability to delegate tasks to vendors and oversee delegated activities.
Ability to train new and existing less experienced QA members.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.