Director, Third Party & Commercial Quality
Edison-New Brunswick Metro Area, NJ
KEY DUTIES AND RESPONSIBILITIES (in order of significance):
- Plan and direct the activities of the Third Party Quality group for all aspects including but not limited to Quality Management System, product disposition and market release, deviations, CAPAs, stability, annual product review, complaints, vendor approval, validation protocols, method transfers, quality agreements and oversight of outsourced activities/third party production. Review and approve new and revised Standard Operating Procedures (SOPs) and other documents. Apply risk management principles in data analysis, decision-making and reporting processes within the areas of responsibility.
- Assure responsible units are compliant with cGMPs, regulatory and corporate compliance requirements and contractual agreements. Provide direction and support within Third Party organization to educate on Quality requirements and GMP requirements.
- Manage communications with Regulatory Authorities including both written and verbal such as for Field Alerts. Responsible for ensuring all third party related Agency communication and/or notification activities are consistent with regulatory and company requirements.
- Manage all external and internal audits by regulatory agencies and customers.
- Responsible for assuring audits are conducted and acceptable prior to selection of third party manufacturers/suppliers of finished product and the evaluation of product acquisitions.
- Plan and manage departmental budgets.
- Lead department performance management of staff including goal setting, direction and coaching.
- Maintain departmental employee recruitment, selection, training, development, safety, promotion and retention levels to ensure proper and effective staffing.
- Perform other related duties or projects, as assigned.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- University Degree in Chemistry, Microbiology, Pharmaceutical Science or related field.
- Minimum of ten (10) fifteen (15) 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.
- Strong leadership experience and abilities, having successfully managed Quality operations in a pharmaceutical, medical device or related industry.
- 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 25%.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Implementing goals, objectives and practices for effective, efficient and cost-effective management of allocated resources.
- Superior communication and presentation skills within and across the organization to all affected stakeholders.
- Negotiating and influencing decisions and presenting information.
- Strategic and analytical thinking, problem solving and decision-making. Critical thinking skills are essential.
- Establishing and maintaining cooperative working relationships with individuals contacted during the course of work.
- Team oriented leadership skills