Director Quality Control Job in Allston, Massachusetts US
Director Quality Control
Description
Description
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
JOB TITLE: Director, Quality Control
DEPARTMENT: Quality Control
REPORTS TO: Vice President, Quality
LOCATION: Allston Landing Facility
The Quality Control department is comprised of the following functions: (1) Chemistry, (2)
Microbiology and Environmental Monitoring, and (3) QC Support which includes analytical equipment
validation, method validation expertise, training, discrepancy resolution, standard/control stability and
trending. The Quality Control department provides strategic leadership, direction, and oversight for the
Allston site 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 Control department makes decisions and conducts activities in Quality within
constraints imposed by broad company policy and government regulations.
POSITION OVERVIEW/KEY RESPONSIBILTIES*:
This positions provides leadership and direction through associate directors, managers or professional
staff. Directs the development, planning, implementation and maintenance of Quality methods, processes
and operations for new or existing products and/or technologies. Develops budgets for labor and capital
expenditures for multiple cost centers and directs the allocation of significant resources to meet financial
performance requirements.
Specific CGMP responsibilities include:
Maintaining a safe, efficient, functional and compliant laboratory developed to the required
standards in accordance with site and corporate guidelines
Providing microbiological expertise and support for product investigations, improvements, etc. to
ensure continued compliance with regulations
Directing the development, planning, implementation and maintenance of QC test methods,
processes and operations
Developing strategies and directing actions to continuously improve data management practices
and test method reliability and repeatability assuring inspection readiness and on time release
expectations
Overseeing complex problems where analysis of situations or data requires an in-depth evaluation
of various factors, root cause analysis and risk assessments
Actively influencing the development and formalization of corporate laboratory control
standards, policies and guidelines
Defining framework for department objectives, operation schedule, processes and budgets
Effectively leading Chemistry, Micro and Bio Chemistry teams supporting strong interactions
with Manufacturing teams
Effectively interacting with other departments - other Quality groups (internal and external),
Manufacturing Bulk and FF areas, MTS, Engineering, Materials, Finance and HR.
Directing Quality Control Support Services (Validation, Analytical Methods and Training)
Specific Leadership Responsibilities include:
Providing effective leadership including: developing and implementing objectives and business
strategies; selecting key personnel and motivating members of the functional area; challenging
employees to develop as leaders while serving as a role model and mentor; assisting with
performance calibration/talent pool management/succession planning; individual goal
setting/performance reviews; training and development; supporting workforce diversity, quality
and safety and supporting supervisors/managers in the management of their
employees/department which support achievement of individual/department/business objectives
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 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.
* Key Responsibilities may differ among employees with the same job title and may change over time, in
accordance with business needs
LEADERSHIP QUALIFICATIONS: N/A if this position does not have direct reports
Leading People
Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams
while managing for high performance and developing others. They are versatile learners and
courageous decision makers
Leading the Business
Genzyme's leaders are effective operating in an evolving, complex and dynamic environment,
providing clear direction and instruction to supervisors and direct reports, and continuously
looking internally and externally for best practices and areas for improvement.
Delivering to Customers
Genzyme's leaders understand patient and customer needs and build relationships as required to
meet manufacturing goals. They create a vision for the organization while continuously
improving operations by holding teams accountable to high standards of performance.
Qualifications
BASIC QUALIFICATIONS:
- Bachelor's Degree in a science or technical field
- 10 years of experience in pharmaceuticals or
a related industry with 8 years in management position or an equivalent combination of
education and experience.
PREFFERED QUALIFICATIONS:
Demonstrated operational excellence of laboratories including lean, 5S
Detailed knowledge of quality management systems
Project management and statistical analysis experience.
Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the
department
Good communication skills at individual, team and organizational levels.
Effective facilitator
Experienced in regulatory affairs and quality assurance
Strong working knowledge of laboratory information management systems (LIMS).
Ability to work in a team environment, facilitate a team approach and communicate effectively
SPECIAL WORKING CONDITIONS:
Ability to gown and gain entry to manufacturing areas
