Location: Phoenix, Arizona, United States
The Senior Director Quality Operations is responsible for establishing the Company’s quality philosophy, policies, practices, procedures, standards, processes and systems by which all Company operations are performed. This position has authority for the site decisions affecting product quality and sustainable cGMP compliance. Participates on the site policy setting teams and leads the site’s Quality initiatives. This position is responsible for assuring individual compliance with the DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and Abraxis policies and procedures.
• Ensures that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMPs and FDA regulations. Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance.
• Makes decisions regarding quality control and compliance for all batches and products, including discrepant batches (investigations, retesting and re-inspections.) Manages the review of complaint investigations. Makes full batch rejection and recall decision in conjunction with Executive Director, Quality Ops.
• Oversees the establishment of all systems, procedures and specifications affecting product quality (e.g., batch records, SOPs, validation protocols and reports) to minimize errors and eliminate the possibility of non-compliant products being produced or released.
• Provides leadership and direction and ensures achievement of all functional accountabilities for the following units: Quality Assurance, Quality Systems and Regulatory Compliance.
• Is the primary contact with the FDA field operations and District Office staffs and liaison during FDA inspections.
• Represents the site for establishment of Company-wide quality policies, strategies and practices.
• Works with site senior management to set site goals and objectives, determine policy and strategic direction, establish and oversee the site budget and coordinate site management.
• Establishes and manages the Quality Operations budget.
• Directs initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
• Oversees the Quality Operations functions of human resources including determining the strategic staffing plan, interviewing and selection, organizational development, managing resources, mentoring and coaching and counseling and performance management and compensation. Ensures all direct reports staff is trained in cGMPs, SOPs, company policies and safety and those employees meet the qualification requirements.
• Reviews and assures adequacy of site staffing, skills, and headcount to support and maintain compliance with cGMP requirements for those management and exempt technical positions directly related to manufacturing and packaging of pharmaceuticals.
• Representative for Phoenix on Commercial Quality Leadership Team for the Americas.
• Requires a Bachelors degree in a related science from an accredited college or university with a minimum of 16 years related experience in a regulated industry, preferably in a pharmaceutical environment, including at least 10 years of progressive management experience.
• Prefer a Masters degree in a related science from an accredited college or university with a minimum of 12 years related experience in a regulated industry, preferably in a pharmaceutical environment, including at least 10 years of progressive management experience.
• An equivalent combination of education, experience and training may substitute.
Requires proficiency in basic MS Word, Outlook, Excel
Requires proficiency in advanced MS PowerPoint, Project, Visio
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong critical reasoning and decision making skills
Requires strong teamwork and facilitation skills
Requires ability to develop others, delegate and motivate
Requires strategic thinking and ability to work independently
Requires ability to interpret / write general business documents
Requires ability to interpret / write technical documents
Requires ability to interpret / write complex business documents
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
Requires strong presentation development and delivery skills
Requires ability to solve routine and complex problems
Level of Supervision
Does not require direct supervision
Impact of decisions
Impacts multiple departments and sites