- BioLife Plasma Services (Boston, MA)
- …wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP, CLIA, and FDA regulations + Experience working in a regulated industry or high-compliance ... environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company-paid holidays + Tuition reimbursement + Retirement… more
- Rhythm Pharmaceuticals (Boston, MA)
- …systems, and learning management systems. + Strong working knowledge of relevant FDA , EU, ICH GMP regulations and guidelines with proficiency in interpreting and ... implementing GMPs in a practical manner. + Proficient in the electronic Quality Management System and electronic Document Management Systems, experience in Veeva Vault is a plus. + Demonstrated ability and eagerness to learn new digital tools and quality… more
- Amgen (Cambridge, MA)
- …and International Conference on Harmonization (ICH) / Food & Drug Administration ( FDA ) mentorship documents related to analytical method transfer and validation. + ... Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing for and responding to RTQ, including assessment of CQAs, product quality targets and attribute risk assessment. + Strong… more
- Takeda Pharmaceuticals (Boston, MA)
- …global regulatory guidelines, expectations and corresponding industry best practices (eg, FDA guidelines, Good Laboratory Practices (GLP)) + Experience in managing ... external work at CROs. + Track record of leading and developing employees and team members is of an advantage. + Being comfortable with working in a fast-paced environment, comfortable with decision-making processes under ambiguity + Ability to work in matrix… more
- Rhythm Pharmaceuticals (Boston, MA)
- …1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA , ICH, EU Regulations and Requirements for Pharmacovigilance required. + Solid ... understanding of cross-functional drug development processes (Regulatory, Clinical Operations, Data Management, and Biostatistics). + Demonstrable organizational and workflow prioritization capabilities + Excellent verbal and written communication skills,… more
- Charles River Laboratories (Cambridge, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Canon USA & Affiliates (Boston, MA)
- …customer relations. + Maintain accurate and complete documentation. + Perform and document FDA and SPD testing on assigned products. + Keep current with latest ... technical developments in multiple product lines. + Support field service operations with technical knowledge on multiple product lines. + Install and maintain equipment in multiple product lines. + Demonstrate expertise in multiple products in 1 modality. +… more
- AbbVie (Waltham, MA)
- …and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA , EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections. + ... Responsible for the strategic leadership of one or more division level quality systems to include SOP Development, Maintenance and Training. Develops, and/or implements the systems across AbbVie operations to assure consistent, high quality products and… more
- Danaher Corporation (Boston, MA)
- …PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further ... regions are a bonus but not a core requirement. + Extensive experience working with cross functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic… more
- Zimmer Biomet (Braintree, MA)
- …Out** + Excellent working knowledge of current USA Food and Drug Administration ( FDA ) and global laws, regulations and standards. + Familiarity with statistical data ... analysis tools and concepts. + Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship. + Proficiency in report writing. + Outstanding organizational skills. + Basic experience or… more