Particle Measuring Systems is seeking a Global Pharma GMP Advisory Specialist to join our team. The Global Pharma GMP Advisory Specialist must be a nationally recognized professional in their field of expertise with well-developed and proven ability to successfully advise clients while also generating new business opportunities. This individual must have a comprehensive understanding of the organization’s advisory models and methodologies, as well as an extensive knowledge of service models. Provides a full range of advisory services to customers in the pharmaceutical industry.
The Global Pharma GMP Advisory Specialist for our Life Sciences division will apply theoretical and practical knowledge of Microbiology, Sterility Assurance, Environmental Monitoring, Trend Analysis, Validation and Cleaning and disinfection process and applications to support Particle Measuring Systems customers and personnel.
Specific Job Duties:
- Works with Advisory team or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions.
- Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives.
- Capitalizes on opportunities to improve project efficiency, results, or team performance and proactively takes action.
- Completes assigned project activities as well as facilitate business decisions.
- Produces quality work that meets the expectations of the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client are met. Manages project engagements (small or large).
- Delivers presentations at seminars and industry group meetings.
- Authors articles for publication in industry magazines, newsletters, book chapters and other forums.
- Provides pre and post-sale technical and application support.
- Analyzes customer data for process improvements and understanding.
- Creates application notes and technical papers.
Advisory Activities and Relationship Management and Business Development
- Applies the appropriate organization’s advisory models and methodologies and assists in the design/improvement the methodologies when needed
- Provides a full range of technical and/or business advisory services within personal area of expertise including representing clients to regulatory agencies
- Completes project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
- Facilitates resolutions to possible problems or conflicts within the project team and/or the client.
- Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
- Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management
Required Skills and Experience
- Bachelor’s degree in a Scientific discipline and a minimum 5 years’ work serving the Pharmaceutical industry required. 8 years plus preferred.
- Sterile production or in Quality Assurance/Sterility Assurance experience is required.
- GMP background required- FDA, EMA, AIFA.
- Excellent written and verbal communication skills, as well as interpersonal skills. Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization.
- English proficiency with the ability to effectively present to customers is required. Secondary language preferred.
- 50%-75% travel; including domestic, international and overnight and/or weekend stays.
- Must have a valid driver’s license, good driving record, and an active Passport or the ability to obtain a Passport.
We are not accepting resumes or calls from outside agencies regarding this position at this time. Thank you for your cooperation.
Please submit a cover letter in the same document as your resume detailing how your qualifications and experience align with the job description to [email protected].
Particle Measuring Systems is proud to be an Equal Opportunity Employer.