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Associate Director, Validation - Analytical Methods-30865Description
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.
The Quality Validation department is comprised of the following functions that approve but do not execute validations: (1) computer systems, (2) cleaning, (3) process, (4) analytical, and (5) utilities and equipment. The Quality Assurance Validation department provides strategic leadership, direction, and oversight for the Allston site Quality Validation function and is responsible for assuring Allston inspection readiness in alignment with global good manufacturing practices, regulatory compliance requirements and current industry/Genzyme policy and guidance. The Quality Validation department makes decisions and conducts activities in Quality within constraints imposed by broad company policy and government regulations.
This position is responsible for assisting in development and definition of the overall Quality Validation strategy and vision for the Allston Landing Facility in alignment with evolving corporate and global regulatory expectations, quality system element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.
Specific CGMP responsibilities include:
- Subject matter expert accountable for site level compliance of validation of CGMP systems to the requirements of US and International regulatory agencies.
- Direct the review and approval processes, resulting in timely and technically appropriate CGMP oversight of validation methods, processes and operations
- Providing guidance to site staff on CGMP requirements for validation, facility, utility, production, equipment, design and operation.
- Routinely assessing and determining optimal organizational structure including resource requirements to ensure compliance and timely completion of priorities in a 7day/3 shift working environment.
- Review and approval of validation studies and developing key performance indicators that will drive validation performance expectations and improvement.
- Developing validation standards for new and existing processes, defining quality and validation standards for new emerging technologies and ensuring these standards apply across all sites
- Providing timely support of the site validation programs, CGMP projects and continuous improvement initiatives
Additional Responsibilities include:
- Providing senior management and staff key input, direction and leadership in support of complex QA Validation challenges related to site initiatives and objectives
Developing a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, and encouraging constructive relationships with manufacturing and support groups.
Training /Deviations /Compliance
- Providing key input and documentation during external and internal regulatory compliance inspections
- Assuring process, cleaning and test method validation requirements, equipment (including laboratory equipment and instrument) qualifications and laboratory controls and compendial compliance are always in state of inspection readiness
- Actively partnering and collaborating with key stake holders during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones consistent with site priorities and objectives.
- Identifying opportunities to improve Quality processes and practices
- Ensuring all Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate
- Genzyme's leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organization.
- Genyzme's leaders are versatile learners who are comfortable with complexity and ambiguity. They are courageous decision makers who are candid and direct.
Leading the Business
- Genzyme's leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious, and create a compelling vision and direction that inspires engagement from their people.
- Genyzme's leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches. They have a track record of generating successful new ideas that improve business performance.
Delivering to Customers
- Genzyme's leaders understand the patient and customer viewpoint. They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
- Genyzme's leaders set ambitious and realistic targets, drive for results, and build accountability within the organization. They set high standards and continuously improve.
- 10 years of experience in pharmaceuticals or a related industry
- 5 years in a supervisory role
- Bachelor's Degree in a science or technical field
- Broad Quality Assurance experience (pharmaceutical and biotechnology):
- Broad validation experience in pharmaceutical and biotechnology
- Knowledge of biotechnology processing and testing
- Project management skills
- Thorough knowledge of GMPs
- Expertise in applying quality principles to manufacturing, facilities and engineering and laboratory testing for the manufacturing of biopharma products
- Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
- Knowledge and experience with discrepancy investigations/validation deviations
- Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives. Strong collaboration skills
- Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
- Driven with a strong focus on goals
- Ability to gown and gain entry to manufacturing areas. *M
Job : Quality
Primary Location : United States-Massachusetts-Allston
Job Posting : Apr 22, 2013
Shift : Day Job
Job Type : Regular
Employee Status : Regular