Primary Responsibilities:    Responsible for the Quality functions for Clinical Development, Manufacturing, and Quality operations. Leads all GxP activities and assures compliance. Ensures compliance of the second source providers: production, testing, clinical manufacturing and packaging, and others. Directs all Quality specific supply chain activities, both internal and external, to support the production plans.    Responsible for all GXP oversight and adherence, including operations, clinical development, and second sources. Ensures that the GXP documentation and practices remain aligned with the current practices such as CGMPs. Ensures that all Quality functions associated with the supply chain such as testing, QA, and batch disposition operate effectively using capacity planning, level loading, scheduling and associated performance metrics.
Tasks Performed:    Reviews all investigations involving quality problems conducted by QA staff and provides appropriate support to ensure necessary corrective actions are taken in a timely manner. Provides formal quarterly updates on the status of the Company’s quality and compliance programs. Ensures that all clinical trial materials are made according to applicable regulations. Ensures that all CMC material coming from Manufacturing and Quality is accurate and meets all safety, potency, and quality standards. Ensures that Quality Operations is properly resourced and has an adequate budget to support all its functions. Ensures the development of all members of the Quality Organization. Ensures that all technology and method transfers are completed effectively and on time. Ensures that AMAG maintains consistently updated on applicable global regulatory requirements such as cGMP’s, ISO, and others such as USP and EP.
Essential Functions:    Responsible for the auditing programs: internal, clinical sites, second sources and others, including clinical manufacturers and packagers, and for assuring that these functions or suppliers remain compliant and providing goods and services of acceptable quality. Responsible for leading the organization towards a culture of quality through the use of continuous improvement on a daily basis. Leads the adoption and use of quality tools to continuously improve the quality of our products and processes. These include but are not limited to SPC, Process Robustness, QbD, electronic batch records, and others. Takes a leadership role in interacting with regulatory authorities during site visits, and responding to formal commitments and/or observations. Represents QA and QC functions of the Company to the pharmaceutical industry and/or government agencies for purposes of promoting corporate interests.
Minimum Physical Requirements:   
Desired Education:   
Desired Degree:     A PhD in Science strongly preferred.
Desired Major:   
Desired Job Experience:    A minimum of 10 years experience in Quality Operations and 3 years as Vice President is preferred. Strong leadership and interpersonal skills and significant knowledge of SPC, QbD, process robustness, and other tools for quality. Proven background in the compliance arena, in sustaining quality levels, and in developing systems such as LIMS, DMS.
Certifications Required:   
Other Qualifications:    Ability to effectively influence others and reach consensus decisions, smoothly implement change, positive can-do attitude and practical problem solving abilities.