Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany â a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your role: The Quality Assurance (Compliance) Supervisor role is to initiate and manage the implementation and maintenance of quality systems supporting operations, product regulatory compliance statements, and regulatory authority requirements for import permits, USDA certification, DMF files, etc. Develop quality team-oriented employees that can respond to business and customer needs without compromising quality.
ESSENTIAL JOB FUNCTIONS
- To demonstrate leadership in developing and implementing quality system initiatives in areas of Operations and Regulatory Compliance.
- Recognize those areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Training, Regulatory submissions, etc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems to ensure a level at or above industry standards.
- Support the Development of project plans for specific quality system initiatives and process improvements.
- Supervise employees supporting this function with respect to day-to-day activity, projects, and performance management.
- Maintain current understanding of GMP regulations for business units including DPM and serum products, and apply and interpret regulations in making business decisions and risk assessments.
- Direct all aspects of maintenance of import permits, generation and maintenance of DMFs, maintenance of USDA certification
- Work with other departments, divisions, and sites to solve problems, improve service, reduce costs, and enhance programs within the Quality Management System
- Act as initial contact with Product Engineering requesting additional information for regulated products, product status, or quality support.
- Provide cost and lead-time information for custom documentation requests or answering quality policy and compliance questions for Sales, Sales support staff, Technical Managers, and other business unit support functions.
- Support process improvement activities
- Support product initiatives or custom business opportunities.
- Maintains and distributes a summary report of quality compliance service levels in-order to respond to changes and requests from Sales, Marketing and R&D.
- Work with other departments or customers to resolve product or service problems to the benefit of the customer and the quality objectives
- Coordinate the selection, training, development, motivation, and evaluation of employees.
WhoÂ you are:
- Evaluate employee performance against expected job requirements.
- Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance in current positions.
- Identify and develop those employees with the potential and interest to pursue supervisory responsibilities.
- Ensure personnel are treated with respect and dignity with and emphasis on providing a strong avenue for communication and company values
- Education: Bachelorâs degree in Science related or health care related field
- Experience: Minimum of 3-5 years of experience inÂ Quality.Â
- Strong leadership skills with a successful track record of personnel development.
- Good understanding of Validation, Qualification, and the following problem solving techniques: Pareto analysis, flowcharts, Root Cause Analysis, and Experimental Design.
- Basic budgetary planning, capital expenditure justification, and basic Finance.
- Knowledge and skills â
- Advanced written and verbal communication
- Good Problem solving
- Ability to organize tasks effectively with good Time Management and multiple tasking capabilities
- Advanced Interpersonal skills with ability to act as a mentor to staff and co-workers.
- Ability to lead & implement Project Initiatives
What we offer: Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.
MilliporeSigma is a division of Merck KGaA, Darmstadt Germany.