Heads of Quality East Coast

Position: Heads of Quality East Coast

Employer:      EMD Millipore Corporation              

400 Summit Drive

Burlington, Massachusetts 01803

Job Site:         17 Cherry Hill Drive

Danvers, Massachusetts 01923

Telecommuting: Telecommuting is available but onsite presence is also required, so the individual must reside within commuting distance of the work place.

Travel: Approximately 20% travel required per year (10% domestic; 10% international).

Responsibilities:

The Head of Quality East Coast will lead quality operations for 7 manufacturing sites on the East Coast and will be responsible for designing programs to focus employees on continuous quality improvement.  Specific job duties include:

1. Ensuring that quality processes, products, and suppliers comply with required quality standards, Good Manufacturing Practices (cGMPs), regulatory commitments, and customer quality requirements.
2. Designing and implementing procedures, processes, and methods to develop and check product, material, components and/or operational quality, including for single use bio processing and filtration systems.
3. Ensuring suitable technical infrastructure and site inspection readiness. Driving the design needs and implementation of connected and collaborative eQA platforms.
4. Analyzing and reporting quality measures, performance, trends and improvements.
5. Providing leadership and direction to execute functional business plans and contributing to the development of a comprehensive quality strategy.
6. Directing the resolution of highly complex or unusual business problems by applying advanced analytical thought and judgment, and in accordance with any applicable laws, regulations, Life Science Standards, or relevant marketing authorizations.
7. Driving important strategic negotiations and influencing key decision makers across the Life Sciences network.
8. Fostering best practice sharing across sites and ensuring application of risk management and sound root cause analysis.

Requirements & Qualifications:

Employer requires a bachelor’s degree in an engineering or science field and seven (7) years of progressively more responsible work experience in any occupation responsible for quality management and quality systems in the life science, biopharmaceutical, or medical device industry.  In addition, a candidate must have:

1. Demonstrated ability in project management including the ability to provide strategy, priority, and direction within life science industry gained through at least seven (7) years of work experience;
2. Demonstrated ability leading a quality organization at a site or business level overseeing all aspects of quality including quality processes as it relates to product development, regulatory compliance, quality management systems, investigations, supplier quality, validations, and product release gained through at least seven (7) years of work experience;
3. Demonstrated ability with government regulations, customer needs, and business needs and demonstrated ability to translate those needs into programs, policies, and procedures that ensure products and services meet established quality standards gained through at least seven (7) years of work experience;
4. Demonstrated ability working with all areas of manufacturing, technical operations, R&D, and the product development process in the pharmaceutical, biotech, food & beverage, chemical, medical devices, or life science industry gained through at least seven (7) years of work experience;
5. Demonstrated ability performing data integrity assessments, audits, and gap assessments to ensure compliance with any applicable policies, procedures, or regulations gained through two (2) years of work experience; and
6. Demonstrated knowledge of manufacturing processes, process automation, and quality process controls for single-use bioprocessing and filtration systems (or similar bioprocessing solutions) gained through two (2) years of work experience.

All years of experience may be gained concurrently.

This position is eligible for EMD Millipore Corporation’s Employee Referral Program.

Applicants can send resumes to EMD Millipore Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req#286508) or apply online at https://careers.emdgroup.com