Must have 10 years of experience in FDA Pharmaceutical Regulatory or Quality Assurance management to be considered for this position.
Phoenix, Arizona based pharmaceutical company seeks a highly engaged experienced, positive team leader within our Quality Assurance and Regulatory area. Candidate must provide regulatory, quality expertise and true leadership to ensure that our company meets its business objectives while complying with the FDA requirements.
Candidate must possess the ability to stay abreast of applicable laws, regulations and provide strong guidance. Candidate is responsible for developing regulatory and quality process strategies, overseeing daily quality assurance within the manufacturing areas, timeline deliverables for new device and drug development as well as handling government and client interactions pertaining to the regulation process and inspections. This is a hands on position.
Summary of Duties:
Direct and oversee all activities related to sustaining quality system protocols and interactive daily oversite.
Daily engagement within position to support international and new drug expansion is a must.
Interpret and apply pertinent laws and regulations governing drugs and devices to meet business objectives. Ensuring manufacturing project teams are meeting company deliverables as outlined within quality systems.
Develop policies, procedures and processes to sustain a high level of manufacturing quality assurance.
Review advertising promotional materials for compliance with governmental regulations.
Develop regulatory strategies and processes for drug development and applications to align with the business plan and (FDA) requirements as well as be an active engaged liaises with consultants and labs.
Actively work with Management and Operations to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications and compounds for US New Drug Applications.
Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Monitor the regulatory process, manufacturing compliance and provide sound oversight assessment of the company’s current and new product areas of interest within the team objectives and environment.
Support and review current as well as the development of new product Standard Operating Procedures (SOPs). Support the Senior Director in the assessment of potential licensing/acquisition.
Stay abreast of new developments and trends across the industry by attending relevant FDA and Industry meetings.
Perform ongoing batch production reviews, verifications and validations of quality system, production and equipment.
Effectively interact and communicate with auditing and inspection agencies. Performing at highest readiness at all times.
Secure and engage consulting staff to facilitate areas of expansion. Overseeing and adhering to budget oversite and consulting needs.
Assists company officers and senior staff members in the development of product formulations, new material acquisition and new procedures in development of new product as well as maintaining high standards of manufacturing.
Achieves optimum employee levels with the least amount of overhead.
Formulates and recommends manufacturing policies and processes that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
Acts as liaison management, manufacturing and team members.
Ensures production is in compliance within current FDA, federal, state and local regulations. Identifies, recommends and implements changes to improve productivity and reduce cost.
Assists and directs the establishment, implementation and maintenance of production standards and equipment needs (e.g., maintenance schedules, training, safety, housekeeping, cost reduction, worker involvement, security, etc.). Initiates and coordinates major projects (e.g., plant layout changes, equipment needs analysis, installation of capital equipment, major repairs, etc.).
Ability to effectively and professionally interface with FDA and Audit Companies to ensure full compliance and glowing results.
High level of personal accountability daily. On time, focused deliverable work ethic. Accountability to be onsite while manufacturing is occurring, minimum hours of 7am-4pm Monday –Friday.
What We Offer
Starting salary $85,000-$120,000 based on experience
Highly competitive company benefits
Income growth opportunities with proven work product.
Health and Dental Insurance Coverage at 100% for full time members.
Three weeks paid time off for full time team members.
Simple 401K Retirement Plan, after one year of employment.
Educational support within QA/RA areas
Experience: 10 years of regulatory affairs or quality assurance experience within the pharmaceutical industry. Pharmaceutical and device experience is required.
Basic understanding of raw materials and chemistry needs within manufacturing environment
Highly engaged, mature, positive long term team member mentality.
Strong competency in understanding regulatory and quality requirements and ability to implement flexible change across areas of manufacturing.
Adherences to strong moral and ethical personal mission statement. A role model for staff members.
Must possess strong mature leadership and interpersonal skills. Ability to work independently and collaboratively, as required, in a fast-paced small family owned team environment consisting of internal and external team members, scientists, and consultants.
Ability to engage, and work with various departmental staff members to ensure all a humbling team mentality is fostered.
Possess strong computer skills and competency in Inventory Management, Project Management software applications, basic MS Office applications - outlook, excel & word in particular.
Excellent oral and written communication skills.
Highly driven, meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously with a positive and enthusiasts demeanor.
Capable of strategic thinking and proposing innovative solutions to regulatory problems and approaches to new product development projects, driving results that create enthusiasm within department and staff.
Knowledge of regulatory and quality requirements for development and marketing of pharmaceutical products. Ability to operate within small company environment