The Association for association professionals in Chicagoland

Parenteral Drug Association (PDA) is seeking an accomplished executive to assume the role of Vice President of Education and Training for PDA’s Training and Research Institute (TRI). This strategic leader will be responsible for developing and executing a comprehensive learning and development vision that strengthens organizational capability, supports leadership growth, and drives performance across a diverse workforce. The ideal candidate will bring proven expertise in enterprise-wide training strategy, a track record of building innovative and scalable programs, and the ability to partner with senior leadership to align talent development with long-term business objectives. 

Responsibilities include:

• Planning, administering, and operation of PDA’s educational programs.
• Developing the TRI budget and operating TRI in a manner so as to achieve the PDA mission.
• Maintaining existing training courses and identifying, analyzing, assessing manufacturing, quality and regulatory affairs opportunities for new training courses
• Ensuring new training courses are identified, developed and rolled out in a timely fashion.
• Identifying and implementing appropriate research projects, to utilize TRI's capabilities and to maintain and improve the TRI facility in Bethesda.

In all cases, the individual works with volunteers, PDA Senior and Junior staff, PDA members and training course attendees (prospective attendees) to ensure the activities are conducted are consistent with the values of PDA and our educational and research program.

Duties & Responsibilities:

Education

• Provides leadership and direction to TRI staff to ensure they have a solid understanding of PDA policies, procedures and strategies. Ensures TRI programs are aligned with those policies, procedures and strategies.  Develops staff, and to the extent possible, prepares appropriate staff succession plans.
• Oversight of the PDA grant team working on the NIH grant for compounders.
• Monitors competitive education offerings and ensures that TRI develops, markets and presents high quality courses that are considered best in class which provide educational content that is current and unique to PDA, emphasizing content that is new and/or updated based on trends and changes in industry technologies and trends.
• Develops PDA continuing education courses, selects instructors and oversees the administration of PDA’s education programs.
• Ensures that TRI course offerings are developed, marketed and delivered in a way that maintains PDAs leadership in this space.
• Evaluates education courses for standards, including quality performance, adjusts course focus, content and/or instructors as necessary.
• Directs the operations of the TRI facility to ensure the facility and equipment are maintained properly and remain an industry-leading value asset for PDA
• Optimizes TRI facility utilization to achieve acceptable ROI, while maintaining quality of education course offerings.
• Proactively seeks opportunities to utilize the TRI facility for research opportunities which will yield results which benefit PDA and the pharmaceutical/biopharmaceutical industry by supporting the scientific quality of PDA Technical Reports, publication of results in appropriate scientific Journals, etc.
• Proactively looks for opportunities to conduct TRI courses at individual company sites. Works with the PDA Global Strategic Advisor responsible for onsite training.
• Seeks and follows up on opportunities to conduct training for government inspectorates; develops programs to deliver inspectorate-desired training.
• Prepares education budget for approval by PDA President and Board, manages TRI operations to meet budget objectives.
• Searches for donations of funding, commodities, equipment, and services to support PDA’s education programs. Ensures appropriate records of donations are prepared and maintained for PDA revenue and tax reporting.
• Works with Marketing to support marketing of education offerings; including providing content and placement recommendations and preparation of articles for inclusion in PDA house organs.
• Writes education focused articles and news column for PDA Letter
• Develops course content and in rare cases, if needed, serves as a faculty member for select TRI courses.
• Represents Education on meeting program committees
• Responds to education-related requests.

Specific to Regulatory, Quality, and Manufacturing

• Monitors with the assistance of the Educational Advisory Board, Portfolio Steering Committee, and Technical Advisory Boards global regulatory, quality, and manufacturing initiatives to identify topics PDA should consider for educational courses
  • Develops interactive relationships with individual regulatory officials to understand training needs both within the agencies and industry.

Education/Experience:

Must possess a Bachelor’s degree (B.S./B.A.) in an appropriate scientific discipline (e.g., biochemistry, biology. chemistry, microbiology, or pharmacy) and a minimum of ten years’ experience in the  pharmaceutical/biopharmaceutical industry, at least 2 -3 years of which must be in a role with significant quality, regulatory, manufacturing exposure.  Understanding of GMP and associated compliance functions is a definite plus.  Should also have some experience in an educational setting, such as training functions, development of technical documents or providing training associated with other job responsibilities.  A minimum of 5 years supervisory/management experience is required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Preferred Skills

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; ability to write speeches and articles for publication that conform to prescribed style and format; ability to effectively present information to top management, public groups, and/or boards of directors.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  Must be able to read and understand common financial reports (budget summaries, P and L statements, cash flow reports etc.)

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Must be able to deal with ambiguity and analyze and determine appropriate courses of actions.

The incumbent must possess the ability to summarize and analyze instructor and course evaluations, as well as more general surveys and questionnaires

Computer Skills:

Proficiency in Microsoft Word, Excel, PowerPoint and Outlook. 

Supervisory Responsibilities:

Supervises and develops TRI staff; including Managers of Laboratory and Lecture Education, Education Coordinators and Assistants and temporary employees as appropriate.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

The noise level in the work environment is usually moderate.  The environment is that of a typical office, with occasional exposure to laboratory and simulated manufacturing operations.  Manufacturing and laboratory projects may raise the nose level and may also involve work near moving or mechanical parts, handling of common laboratory chemicals, solvents and cleaning and sanitizing agents.  On a limited basis, the individual may occasionally work around fumes or airborne particles or with toxic and/or caustic chemicals.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Overnight domestic and international travel will be required on occasion

• Ability to independently ascend and descend stairs;
• Ability to independently reach, twist and bend;
• Ability to independently remain stationery for extended periods of time; and
• Ability to independently lift up to 50 pounds when required by work assignment.

About Parenteral Drug Association

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide.

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