Director Quality Control QCRM Job Listing at Genzyme Corporation in Northborough, MA (Job ID Genzyme_feed.xml_31961)

Biotechnology, Pharmaceutical

Director Quality Control-QCRM-31961

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Genzyme is seeking a Director for the Quality Control Raw Material Department. This is an exciting position accountable for providing leadership, developing the strategy and overseeing the execution of raw material disposition, life-cycle management of corresponding quality and laboratory control systems, including timely completion of key consent decree commitments in accordance with appropriate regulatory, corporate and scientific guidelines. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. This person leads, develops and mentors reporting staff at a variety of levels.
Description:
· Develop the overall QC Raw Material strategy and vision for Framingham/Northborough in alignment with evolving corporate and global laboratory standards, consent decree and quality system element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment

· Actively work in a matriced environment to remediate numbered consent decree steps and quality standard gap assessments primarily related to method validation, supplier qualification, material and laboratory controls
Partner with Strategic Planners across the Genzyme network to ensure long term/short term alignment of demand forecast with laboratory planning/prioritization and enable manufacture operations continuity
· Oversee development and coordinate execution of integrated project plans to ensure timely completion of all quality system, internal and external regulatory compliance commitments
· Provide guidance, and ensure development and routine trending of key performance indicators (i.e., productivity, compliance, training, safety); ensure timely implementation of corrective actions in alignment with trending observations
· Participate and influence the development and formalization of corporate standards for supplier qualification, material and laboratory control programs
· Provide input, direction and leadership in support of complex QC Raw Material challenges related to site/global initiatives and objectives
· Act as champion for continuous improvement and work diligently to establish the QCRM department as a Centre of Excellence within the Genzyme network
· Mentor and develop personnel, including supervisory/management staff via robust developmental discussions, external feedback and documented goals/objectives; routinely assess key talent and establish a succession plan for all managerial personnel
· Define framework for department objectives, operation schedule, processes and budgets
· Foster an open, transparent and teamwork culture
· Accomplish results through lower management levels and build a culture of execution and delivering on results
Consistently operates the organization in a planned, predictable manner by reliably executing plans, initiatives and compliance requirements
Partner with Planning; Materials Management and Procurement to incorporate QC RM testing lead times, capacity and material qualification/certification requirements into an overall all demand forecast resulting in planned work
Develop and maintain metrics and processes that insure QCRM is always in a state of inspection readiness for all related key Quality Systems including deviations; change control; CAPA; laboratory investigations and Supplier Management

Qualifications
Basic Qualifications:
12 years experience in a QC/QA cGMP environment within the pharmaceutical or biotechnology industry
10 years of personnel management experience
Experience with project management, compendial requirements, ICH method validation principles, CGMP's/harmonized regulatory requirements
Experience presenting information to the FDA and preparing regulatory responses

Preferred Qualifications:
Bachelor's Degree in Life Sciences discipline
Experience with implementation and management of LIMS, including laboratory instrumentation, and software interfacing
Proven record with developing and establishing successful QC or QA organizations
Method development/optimization experience
Experience in Quality electronic systems such as Trackwise and Plateau
Firm knowledge of root cause and risk analysis tools and applications
Must have knowledge of personal computer operation and appropriate word processing, database, project management and spreadsheet software.

M*

Job : Quality
Primary Location : United States-Massachusetts-Northborough

Job Posting : Apr 29, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular