Pharmaceutical Audit Project Manager

Boston, BostonAbout NSF InternationalFounded in 1944, NSF International is committed to protecting and improving human health on a global scale. NSF International is an independent, not-for-profit organization that provides standards development, product certification, auditing, education and risk management for public health and the environment. Manufacturers, regulators and consumers alike look to NSF International for the development of public health standards and certification that help protect the world's food, water, health and consumer products.Job DescriptionDepartment Description:

NSF International is an independent organization that certifies products and writes standards for food, water and consumer goods to minimize adverse health effects and protect the environment (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.

NSF-DBA, an NSF International company, provides expert training and consulting services to the pharmaceutical, biotech and dietary supplement industries in the fields of quality management, regulatory compliance and high-quality training. NSF International acquired DBA in 2007 to expand its range of health science services on a global scale and in 2010 more than 60 training sessions were delivered to the pharmaceutical, biotech and dietary supplement industries.

Detailed Description:
Coordinate and oversee second party 21 CFR 211 GMP audits of OTC (over-the-counter) and generic pharmaceutical drug manufacturers.  Manage and track projects using standard project management tools.Write project proposals, which includes details on project and audit design, timeline and pricing.  Ensure that resources and capabilities are in line for the execution of all phases of the projects. Prepare and maintain project setup sheets and give regular updates to management, working within NSF software systems (Oracle, LIMS, etc.).Partner with Marketing Department to assist in the development of marketing items and provide technical review of marketing and sales literature.Partner with Business Development Manager(s) to identify targets and develop proposals for pharmaceutical auditing services.Occasional travel domestically/internationally for evaluations, testing, client visits, and trade shows.Develop and maintain standard operating procedures, checklists, and records as necessary.  Interface with consultants and trainers on projects involving services.Provide assistance to colleagues with coordinating NSF-DBA training courses as needed.Provide service which leads to customer satisfaction and repeat business.Perform other duties, as assigned.

Job Requirements:

REQUIRED QUALIFICATIONS:

Bachelors degree; in a Science related field, particularly chemistry/biologyAt least five (5) years experience in a pharmaceutical manufacturing environment, including experience in providing excellent customer service.Familiarity with regulatory requirements in the areas of pharmaceuticals, particularly OTC or generic prescription pharmaceuticals drugs.A good working knowledge of pharmaceutical cGMP as detailed in 21CFR Part 21Experience with Microsoft Office Suite, i.e. Word, Excel, PowerPoint, Outlook, etc.Willingness and ability to travel up to 25% of the time.Ability and willingness to learn required technical information; possess a technical bent.Excellent written and verbal communication skills.Ability to work well with others, engaging personality.Ability to work independently and follow through on assignments with limited direction.Excellent attention to detail. Strong time and project management skills.Ability to learn new technical areas outside of primary area of expertise.Strong technical writing skills.Excellent interpersonal and presentation skills.

PREFERRED QUALIFICATIONS:

Graduate degree in a scientific discipline.Familiarity with regulatory requirements in the area of pharmaceuticals and/or medical devices.Previous experience with compliance and quality systems.

Additional Details:

PHYSICAL DEMAND:

Required to sit for long periods of time.Light physical effort required (ability to move 50 lbs. from one area to another).Ability to travel domestically and internationally up to 25% of time

WORK ENVIRONMENT:

Work performed in an office environment.Some work takes place in manufacturing or other non-office setting.
Smoke free work environment.

How To Apply:
No phone calls, faxes or postal mail please.


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