Sunrise System Inc. is currently looking for Sr. Mgr., Third Party & Commercial Quality in Madison, NJ with one of our top client.
Job Title: Sr. Mgr., Third Party & Commercial Quality
Job Id: 19-10777
Location: Madison, NJ 07940
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
- Be part of the dynamic Third Party & Commercial Quality (TPCQ) team responsible for a portfolio
of products that include Natural Health Products, Cosmetics, OTCs and Drugs.
- Under general direction, manages the evaluation of products supplied to the Company from the
- Third Parties and assures that the product is manufactured and controlled in accordance with Company standards, registrations and regulations, both domestically and internationally.
Job Qualifications (Minimum Requirements)
- Education and Experience
- University Degree in Chemistry, Microbiology, Pharmaceutical Science or related field.
- Minimum of seven (7) - ten (10) years of progressive management experience; preferably in the pharmaceutical industry and including engagement of outsourced service providers such as manufacturers and packagers.
- Extensive knowledge of the Regulations/GMP’s and experience with regulatory authorities including at a minimum the FDA.
- Knowledge of other global regulatory authorities is an asset.
- The ability to influence vertically and horizontally across the organization is essential.
- Must be able to travel, including outside of USA.
- Travel is estimated to be 20%-25%.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Strong knowledge of drug regulations and guidelines.
- Knowledge in Canadian, European and other global regulations also an asset.
- Pharmaceutical processes, principles, practices and their application.
- Responding to inquiries from management, employees and regulatory agencies.
- Researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.
- Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolution
- Administering, and interpreting contractual agreements.
- Excellent interpersonal, oral and written communication skills.
- Demonstrated leadership in managing projects and/or product launches and ability to work independently.
- Excellent negotiation, problem solving and prioritization skills.
- Strong time management skills, able to manage multiple projects, duties and assignments.
- Ability to work in a team, both in person and remotely and across various departments.
Direct: (732) 272 0298 | Email: Abdul.A@sunrisesys.com
Direct: (732) 272 0265 | Michael@sunrisesys.com
Complex Problem Solving