Senior Director, Quality Operations Job

Location: Phoenix, Arizona, United States

POSITION SUMMARY

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.

 

ESSENTIAL FUNCTIONS

• 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.

 

EDUCATION/EXPERIENCE REQUIREMENTS

• 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.

 

 

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Qualifications

Computer/Software Skills

Requires proficiency in basic MS Word, Outlook, Excel

Requires proficiency in advanced MS PowerPoint, Project, Visio

Compliance Knowledge

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

General Competencies

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

Written Communication

Requires ability to interpret / write general business documents

Requires ability to interpret / write technical documents

Requires ability to interpret / write complex business documents

Training Skills

Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance

Requires strong presentation development and delivery skills

Problem Solving

Requires ability to solve routine and complex problems

Level of Supervision

Does not require direct supervision

Impact of decisions

Impacts multiple departments and sites