International Regulatory CMC Liaison Specialist MA
2/9/2016 6:53 AM

Primary Role:
1. Act as liaison between the in-country International RA Team and GRA in Lexington for any CMC and Quality/Regulatory compliance related issues and projects
2. Liaise between the CMC GRA team members and international regulatory leads for developing, providing and executing CMC regulatory strategies and submissions.
3. Responsible for guiding and  ...View Job

Associate Director, Regulatory Process and Standards MA
2/5/2016 6:50 AM

Primary Role
The Regulatory Process Standards Lead will further the vision for Global Regulatory Affairs (GRA) in alignment with the One Shire business model to establish and document global process and standards. This position will collaborate with all functions within GRA to design optimum Shire Regulatory processes and interfaces between GRA and Shire functions and cont  ...View Job

Senior Principal Engineer, Drug Product MS&T PA
2/4/2016 6:29 AM

Primary Role

This is an exciting, frontline, technical role in a rapidly growing biopharmaceutical company, where we outsource 100% of all our manufacturing, packaging and testing activities. This key role supports new product and technology introductions, transfers, and technical oversight of commercial products within the Global Supply Chain organization of Shire T  ...View Job

QA Specialist-Operations - Alewife MA
2/1/2016 6:52 AM

Primary Role
Routine management & coordination of GMP compliance systems and policies for Alewife facility. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Review of production records for compliance. Assures cGMP's an  ...View Job

QC Investigator MA
1/29/2016 7:19 AM

Primary Role
Job Summary:
Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, docume  ...View Job

Document Management Operations Lead MA
1/29/2016 7:19 AM

Primary Role
Manage team responsible for and function as an advisor of GMP/GDP Document Processing, including but not limited to Controlled Documents (SOPs, Work instructions, Forms, Master Batch Records, Specifications, Test Methods, Protocols and Reports, and Periodic Review process.) and Managed Documents (Guidelines, Best Business practices).

Functions as a  ...View Job

Validation Manager - Utilities/Facilities - Cambridge/Alewife MA
1/27/2016 6:41 AM

Primary Role The individual will be responsible for supervising staff at the Alewife, Cambridge, MA facility. Technical duties include setting validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections. Leadership duties include developing s  ...View Job

Senior Validation Engineer II Automation - Cambridge/Alewife MA
1/27/2016 6:41 AM

Primary Role:

This position will be responsible for leading control systems validation activities for Shire including projects associated with PCS, BMS, BAS, CMS, OSI PI, and other Shire automation upgrades.

Technical duties include setting validation strategy, writing, executing, reviewing and approving validation documents, adhering to domestic and inter  ...View Job

Global Medical Team Lead - HAE MA
1/22/2016 6:52 AM

Primary Duties

  • Leads development and execution of multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
  • Serves as the global expert within Shire in support of the product/disease area incl. the respectiv  ...View Job
Sr. Director Regulatory Affairs Ad/Promo MA
1/21/2016 7:31 AM

Primary Role:
The Senior Director, US Advertising and Promotion (A&P), is accountable for the Shire GI/IM/HAE & OPTH and other Business Unit products as directed with regard the CMLR process. This process defines the review of promotional and other materials through CMLR as directed and as per policy. The role is jointly responsible for the development, implementat  ...View Job