Senior Director - Quality Assurance - AMAG Pharmaceuticals - Waltham

Job description
PRIMARY OBJECTIVES:
The Sr. Director/Director will lead and continue to develop with enthusiasm and positive energy a QA organizational structure to support QA compliant operations so that QA is valued as a talented, collaborative, results oriented group that responds to their internal and external customer’s needs. This position will also provide strategic input to AMAG Pharmaceuticals, Inc. on quality initiatives, and coordinate Quality Assurance activities relating to all GxP operations for development and commercial products as well as devices.

DUTIES/RESPONSIBILITIES:
Working in partnership with the regulatory affairs, clinical, PV, technical operations, and quality control, the Director/Sr. Director, Quality Assurance will work to develop and implement programs for appropriate GxP compliance.
Provide compliance oversight, either personally or through staff, of all GMP activities at AMAG
Pharmaceuticals and its contractors. Additional GMP responsibilities involve regulatory reporting, product complaint and quality investigations as well as leading regulatory inspections.
Provide compliance oversight, either personally or through staff, of all GCP activities at AMAG Pharmaceuticals and its contractors, including audits of clinical trial sites, clinical research organizations, testing laboratories, AMAG Pharmaceuticals clinical files, etc. Additional GCP responsibilities involve reviewing and approving clinical protocols, clinical reports and associated investigations, and participating in regulatory inspections.
Provide compliance oversight, either personally or through staff, of all PV operational activities at AMAG Pharmaceuticals and its contractors,
Develop/improve Quality Systems, programs, and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards. The Director/Sr. Director QA will have primary responsibility for external/internal audits, QA PV, QA operations, clinical operations, product complaints, vendor management, quality systems, document management, training, as well as corporate and operations quality councils.
Provide continuity, consistency and compliance to Out of Specification (OOS) Investigations, Deviations, Non-conformances and other events in external Quality Control Laboratories and Manufacturing facilities. Provide oversight at multiple contractor sites; ensure timely resolution of events, and also serve as a backup for review of GMP documentation during periods where a high volume of such records is being reviewed.

Desired Skills and Experience
EDUCATIONAL REQUIREMENTS:
Bachelor's Degree or above in a Science/Engineering or related field. A minimum of 10 years experience in the pharmaceutical industry and in quality assurance, including direct experience in a GxP environment.


EXPERIENCE/QUALIFICATIONS:
Must have demonstrated leadership skills including clear written and oral communications, good motivational skills and establishment of high standards.
Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management of the company and extensive knowledge of pharmaceutical/biotech industry and FDA, ICH and in-depth knowledge of GxP regulations.
Ability to lead and motivate others to meet company goals and objectives.
Ability to direct others in a matrixed environment in order to accomplish goals and objectives.
Ability to leverage internal and external resources to manage QA activities for multiple programs.
Ability to handle multiple tasks while working against pressures of deadlines. Ability to manage and delegate multiple tasks while maintaining focus on quality results and compliance with local procedures, corporate guidelines and Federal agency regulations. Must be mature, self-motivated team player with exceptional organization, time management, and people skills. Superb organizational skills and attention to detail and must be able to properly prioritize various tasks and projects. Strong public speaking skills; ability to present technical information on quality systems to management and all employees.
A minimum of 10 years of related and increasingly complex quality assurance experience in the pharmaceutical industry is required. Candidates should have demonstrated experience in QA as it relates to drug substance and drug product manufacture and testing, toxicology studies, clinical trials, investigations, change control, validation and/or audits. Additionally, candidates should demonstrate the ability to manage staff, delegate responsibility, and work effectively with diverse departmental groups. Skills with processes involved in manufacturing and distribution, QC, validation, clinical studies and/or toxicology studies, excellent communication (both written and oral), facilitation and presentation skills, and thorough knowledge of FDA regulations are also necessary.
Strong background and demonstrated effectiveness in quality assurance and compliance of FDA regulated parenteral products.

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