Snr. Manager, Third Party & Commercial Quality
Edison-New Brunswick Metro Area, NJ
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.