Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Essential Duties and Responsibilities
· Ensures all company, records and programs are compliant and meet industry and regulatory requirements and expectations for registration and operation as a 503B outsourcing facility.
· Maintains currency with changes in FDA, DEA and states guidelines, rules, regulations and standards for 503B and GMPs for all company operations, communications and records.
· Leads company liaising and negotiating with regulatory authorities for registrations, licensing, inspections, reporting and other communications; Manages interactions accordingly with FDA and other regulatory agencies.
· Ensures effective knowledge sharing and communication of best regulatory and quality practice throughout the organization.
· Creates and communicates a compelling vision for industry and regulatory compliance within the organization that supports both corporate and functional mission and goals.Executes strategic and tactical regulatory plans to ensure the company’s global growth plans are achieved in a timely and compliant manner; similarly oversees and guides compliance in Quality Unit plans and operations.
· Develops strategic plans that ensure regulatory compliance for GMP quality of services agreements with suppliers, vendors, contract test labs (CTL) and contract manufacturing organizations (CMO).
· Ensures compliance and serves as an internal subject matter expert for all GMP regulatory and quality related areas within the organization, including product development activities and process improvements for existing product offerings as well as for new product pipelines.
· Develops a compliance program and team within the organization to audit internal activities within the company as well as vendors, service providers and CMOs/CRO’s. Implements the appropriate management oversight is in place with external supporting organizations to ensure Company is responsible for the quality of their products and services.
· Develops and reports appropriate metrics that monitor the quality health of the company. Ensures metrics are visible at all levels within the organization and that suitable corrective and preventative actions are implemented to address shortfalls Implements a Quality Management review process to ensure senior management are actively involved in managing quality within the company.
· Maintains an effective Quality Management System that meets the expectations of various regulatory bodies and partner clinics,as required Assesses the appropriateness of the Quality Management System on a annual basis and makes recommendations to senior management for improvement.
· Provide direction and support to quality units and manufacturing teams, ensuring management regulatory understanding in the oversight of business activities.Aids in the development of global quality policies,procedures and tools to ensure consistency of compliance and quality is maintained.
· Develops and maintains effective working relationships with appropriate quality bodies, professional associations, external experts and key opinion leaders. Represents the company and actively participates in global industry quality groups that work to influence global quality related activities.
· Effectively builds organizational compliance and quality knowledge and capabilities necessary to achieve organizational goals and functional objectives, including recruiting and developing talent of high technical and leadership caliber. Coaches departmental staff on specific performance and professional development issues.
Qualifications, Experience and Knowledge
Minimum required BS or BA degree, preferably in science, allied health, or engineering field; Master’s level is desirable.
Certification in Regulatory Affairs with current membership in Regulatory and/or Quality professional group(s) are recommended.
Minimum of 7-10 years GMP regulatory experience including a leadership role within a organization structure in the pharmaceuticals, compounding pharmacy, food, cosmetics or other FDA regulated industry.
Understanding of FDA regulations, GMPs, SOPs,and current compliance issues/concerns is essential.
Experience with direct exposure to FDA an other regulatory bodies for GMP inspections, DEA inspections, FDA oral and written communications, registrations and product approvals.
Experience in developing and managing a compliance program to support business goals.
Experience, knowledge, and skills in GMP manufacturing Quality Management System operations is within an organization important.
Proven ability to develop, lead, manage and interact with cross-functional / cross-divisional teams.
Ability to work in an FDA and state’s regulated industry with diverse and changing requirements and regulations.
Ability to deal with ambiguity and the corresponding capacity to make decisions or recommendations based on potentially incomplete information.
Demonstrated ability to build, lead and partner with effective teams.
Experience providing quality oversight to vendors, third party contractors and service providers.
Internal Number: 5981
About Grafton Inc
We have a reputation for forming strong partnerships with our science and technology clients.
We work to understand your staffing goals and company culture so we can develop creative solutions to meet your recruiting needs.
Our clients span many industries, including:
• Animal Health
• Food Science