Manager, Exceptions – Alnylam – Cambridge, MA, USA
Alnylam Pharmaceuticals, one of Cambridge’s most innovative, publicly traded biotech companies, focused on translating the science of siRNA into human therapies is seeking an experienced QA Manager/Sr. Manager in the Supply Chain QA function, to lead quality assurance of contracted labeling and packaging operations. This position will be responsible for developing quality systems for managing clinical and commercial labeling and packaging operations at Contract Manufacturing Organizations (CMOs) and will support selection and qualification of vendors. Knowledge and experience of cold chain management, serialization and good distribution practices is desirable.
Summary of Key Responsibilities:
- Partnering with the Supply Chain group to develop and implement Quality Systems for labeling and (primary and secondary) packaging controls, including
- Specifications development
- Artwork and Proof Reading
- Packaging and Labeling Process Qualification
- Shipping / Transportation Qualification
- Commercial Packaging Vendor Qualification
- Knowledge of regulatory requirements in areas of L&P, packaging design standards, warehousing & distribution, device/ combination products
- Experience in facilitating and/or participating in Risk Assessments
- Knowledge in serialization, RFID technology and product security experience is desirable
Qualifications:
- A minimum of Bachelor’s degree in sciences or engineering
- A minimum of 8 years of experience in a GMP manufacturing and/or supply chain environment
- Experience in contributing to regulatory filings and inspections
- Good understanding of FDA and EMA regulations and guidelines
- Good understanding of CMO mediated Supply Chain activities
- Excellent organizational, communication, and interpersonal skills
- Ability to sustain 20% domestic and international travel
- Clear alignment with Alnylam Core Values:
- Commitment to People
- Innovation and Discovery
- Sense of Urgency
- Open Culture
- Passion for Excellence
