Director Quality Assurance

Director Quality Assurance

Responsibilities

The Director Quality Assurance is responsible for ensuring the quality of licensed and clinical products manufactured at the teams focused on quality oversight of day-to-day site operations raw material release and drug substance lot disposition.

Responsible for ensuring the quality of licensed and clinical products manufactured at the facility. Provides leadership and guidance to other functional areas in areas of regulatory compliance quality practicesand quality systems.

Communicates company goals safety practices and deadlines team members provides guidance and leadership assesses performance and helps with the development of direct reports.

Good understanding and wide application of scientific and technical principles theories and concepts in the understanding ofcGMPsand knowledge of both US and international regulatory guidelines and standards. Excellent understanding of quality systems like non-conformances CAPAandchange with the use of OE tools/lean manufacturingutilizingtools such as DMAIC and root cause to review and understand analytical data.

Experience in building action plans problem solving and decision makingin a timely mannerfor on-budget on-time objectives.

Ability to identify and creatively resolve complex problems at a site-level through good decision making utilizing functional and broad-based technical skills and leadership capability. Ability to manage conflict and stand alone on issues. Ability to provide constructive feedback to staff.

Ability to develop strategic initiatives and assist in translating them into tactical solutions. Ability to develop strategy and negotiate senior management approval. Good appreciation of the business environment. Demonstrates broad understanding of the science and technology that drives the business.

Generally accomplishes results through lower management levels. Determines and establishes organizationalstructures and supervisory relationships subject to top management approval. Often responsible for managing a major segment of the company.

Decisions would affect the financial employee or public relations posture of the the organization unit as prime internal and external contracts or operations.

Conducts briefings and technical meetings for top management and customer representatives. Interacts with top level-level managers concerning matters of significance to business and product quality to ensure customer expectations are met.

Activelistening skills interpersonal savvy andexcellentpeer relations. Ability to effectively present complex data and strategy to large groups.

Accomplishes results through the management of a team of professional employees and/ormanagersand other leaders. Acts as an advisor to subordinate supervisors or staff members. Develops and administers budgets schedulesobjectivesand to managing teams and daily operations.

Accountabilities

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and support Policies and Standards on time. Report potential issues of non-compliance.

In addition for Managers and Project Team Leaders:

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards (b) ensuring completion of all required training (c) fostering a culture of openness in which employees are comfortable raising questions or concerns and (d) immediately addressing and reporting as appropriate instances of non-compliance.

• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance Team Management Performance Management Individual Development Planning Talent Management Recruitment People information SHE accountabilities and Fiscal and Financial awareness.

• Leaders with accountability forGXPareas are expected to understand the legal and regulatory requirements of their roles in providingappropriate resources(which could be human financial material facilities and equipment) tomaintainthe Quality system and continually improve its effectiveness.

Essential Qualifications Skills and Experience

• Bachelors Degree
• 15 years in biotech /pharmaceutical industry
• 10 years management experience
• 5 years Biologics Quality experience

Desirable Qualifications Skills and Experience

• Biologics drug substance Manufacturing and/or Quality experience
• Biologics lot disposition experience

The annual base pay for this position ranges from $174856 to $ positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.