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.
This position provides leadership and direction to the Quality Operations organization. Establishes current and long-range objectives and sets operating plans for areas of responsibility. Allocates resources - human, financial, technical etc - to fulfill near term goals and commitments while building towards sustainable manufacturing excellence. It is the responsibility of this position to motivate and lead his/her organization according to Genzyme policies to achieve business objectives that will have a major impact on the success of the Corporation. The Director, Quality Assurance will direct the day-to-day operations of QA and will provide leadership, management and oversight activities the organization.
Specific cGMP responsibilities include:
Ensuring the management and continuous improvement of the QA Operations and Technical Services
Directing the review and approval process resulting in timely and technically appropriate
cGMP oversight of GMP operations and document
Providing guidance to site staff on CGMP requirements
Ensuring sound release decisions that adhere to multiple jurisdictional requirements
Establishing and chairing the nonconformance review board for all significant deviations ensuring that sound decisions are applied to adequately investigate root cause and ensuring appropriate CAPA's and CAPA effectiveness are applied
Quality approval for all critical risk assessments and corresponding CAPA's
Ensuring that all product quality related decisions adhere to current GMP and regulatory requirements
Continuously improving all Quality oversight interactions
Providing effective Quality leadership during internal and regulatory inspections
Ensure deviations, discrepancies, change controls, etc. are technically sound from a quality standpoint
Specific Leadership Responsibilities include:
Ensuring compliance with all legal and business requirements and Genzyme policies and practices.
Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets.
Strengthening overall leadership and organizational capabilities in area of responsibility.
Building and sustaining a high performance management team and ensuring strong alignment and coordination with other functional groups at the site.
Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations.
Participating in development of site long range in line with the corporate Long Range Planning.
Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
Motivating, retaining and developing key employees. Building and sustaining employee
engagement by creating an environment within which individuals and teams can excel.
Interacting closely with the Business Unit, relevant sites and functions to define production plans, yearly goals and budgets for reporting functions/operations as well as long range.
Maintaining an external network of expertise and representing the company in professional organizations
Represent the Quality organization in interactions with other functional units
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.
12 years of experience in pharmaceuticals or a related industry or a MS in science/engineering and 10 years experience; 8+ years in management position ; 8+ years specific Quality Assurance experience in a pharmaceutical or biotech organization
Significant knowledge and experience with FDA/EMA/TGA/HC regulations
Bachelor's Degree and 12 years of experience in pharmaceuticals or a related industry or a MS in science/engineering and 10 years experience; 8+ years in management position ; 8+ years specific Quality Assurance experience in a pharmaceutical or biotech organization.
Broad Quality Assurance experience in:
Knowledge of biotechnology processing and testing
Proven experience in leading a multi- tiered and quality diverse operation
Proven experience in establishing a Plant QA function for the approval of batch records, BOM, Work orders, CAPA's and Change Controls in an efficient and sound process
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 investigation and lot disposition
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
State or Province