AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products
across a range of therapeutic areas, including women's health. In addition, AMAG seeks to collaborate on and acquire promising therapies at various stages of development, and advance them through the clinical and regulatory process to deliver new treatment options to patients. For additional company information, please visit www.amagpharma.com.
Duties & Responsibilities:
To include but not limited to the following:
Manages release of AMAG products based on data review and analysis of analytical data generated against established test specifications
Serve as a QC SME on cGMP in-process, release, and/or stability testing.
Establishing stability program strategy and oversight of commercial annual commitments and enrollments.
Maintain active purchase orders to insure that testing can be performed at all our contract test labs.
Supports real-time trending of stability data to identify and actively manage Out of Trends (OOTs) and Out-of-Specification (OOS) investigations for lots on stability.
Assist in the maintenance of QC performance metrics/KPIs in evaluation of external vendor(s) performance.
Oversight of AMAG stability program.
Support AMAG regulatory filings, submissions, and annual product reviews to support annual regulatory commitments and timelines.
Oversight of AMAG relevant document revisions as SME and approvals at external vendors.
Author/revise AMAG policy documents and SOPs as needed.
Supporting AMAG continuous improvement and ongoing compliance initiatives.
Reviews external manufacturer documentation and analytics. Reports findings back to AMAG senior management along with
Manage coordination of AMAG test samples to external testing laboratory(s) for testing, including sample and shipping information, as necessary
Arranges and manages vendor meetings to discuss QC topics
Acts as QC point of contact for interface and communication between AMAG and external parties (manufacturing and testing labs)
Manage and participate in vendor investigations, OOS, and OOT
Bachelors or Master's degree in Chemistry/Biology or related science field with 5 years+ experience with QC /GxP analytical testing, method development, transfer, validation, and/or GxP stability programs. Candidate should have 3 years of external vendor management experience (domestic and/or international).
Proficient knowledge in current regulations and guidance documents including cGMP, ICH, FDA, and EMA requirements.
Strong analytical skills for interpreting data and stability trending. Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc) preferred.
Ability to work in a virtual environment with external vendors and collaborators.
Flexible and adaptable to changing and evolving priorities and needs.
Excellent communication and written skills to successfully partner with internal collaborators and external vendors.
Previous experience with an EDMS system preferred.
Decision - Making:
Identifies issues and creates solutions to address gaps and short/long-term initiatives.
Escalates issues that can have a potential impact to overall compliance, technical and/or business operations to QC Management.
Amag Pharmaceuticals, Inc.