Director Quality Assurance

AstraZeneca•Frederick, MD

10h•Onsite

About The Position

The Director Quality Assurance is responsible for ensuring the quality of licensed and clinical products manufactured at the facility. This role oversees teams focused on quality oversight of day-to-day site operations, raw material release, and drug substance lot disposition. The Director provides leadership and guidance to other functional areas in regulatory compliance, quality practices, and quality systems. They communicate company goals, safety practices, and deadlines, while motivating team members, providing guidance, assessing performance, and aiding in the development of direct reports. This position requires a good understanding and wide application of scientific and technical principles, theories, and concepts, with an excellent understanding of cGMPs and knowledge of US and international regulatory guidelines and standards. An excellent understanding of quality systems like non-conformances, CAPA, and change control is also essential. Familiarity with OE tools/lean manufacturing, utilizing tools such as DMAIC and root cause analysis, is expected. The role involves reviewing and understanding analytical data, and experience in building action plans, problem-solving, and timely decision-making for on-budget, on-time objectives. The Director must be able to identify and creatively resolve complex site-level problems through sound decision-making, utilizing functional and broad-based technical skills and leadership capability. They must also be able to manage conflict, stand alone on issues, and provide constructive feedback to staff. Developing strategic initiatives and translating them into tactical solutions, as well as developing strategy and negotiating senior management approval, are key responsibilities. A good appreciation of the business environment and a broad understanding of the science and technology driving the business are also important. The Director generally accomplishes results through lower management levels, determines and establishes organizational structures and supervisory relationships (subject to top management approval), and is often responsible for managing a major segment of the company. Decisions made in this role would affect the financial, employee, or public relations posture of the company. The Director represents the organization unit as prime internal and external contacts or operations, conducts briefings and technical meetings for top management and customer representatives, and interacts with top-level managers concerning matters of significance to business and product quality to ensure customer expectations are met. Active listening skills, interpersonal savvy, and excellent peer relations are crucial. The ability to effectively present complex data and strategy to large groups is also required. The Director accomplishes results through the management of a team of professional employees and/or managers and other leaders, acting as an advisor to subordinate supervisors or staff members. They develop and administer budgets, schedules, objectives, and goals, and independently determine their approach to managing teams and daily operations. Accountabilities include conducting activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards. This includes completing all required training, reporting potential issues of non-compliance, and for Managers, ensuring and monitoring compliance by team members and third parties through positive reinforcement, ensuring training completion, fostering a culture of openness, and addressing/reporting 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 for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources to maintain the Quality system and continually improve its effectiveness.

Requirements

Bachelor's Degree
≥15 years in biotech /pharmaceutical industry
≥ 10 years management experience
≥ 5 years Biologics Quality experience
Good understanding and wide application of scientific and technical principles, theories, and concepts in the field.
Excellent understanding of cGMPs and knowledge of both US and international regulatory guidelines and standards.
Excellent understanding of quality systems like non-conformances, CAPA, and change control.
Familiar with the use of OE tools/lean manufacturing, utilizing tools such as DMAIC and root cause analysis.
Ability to review and understand analytical data.
Experience in building action plans, problem solving and decision making in a timely manner for 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 organizational structures 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 company.
Represents 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.
Active listening skills, interpersonal savvy, and excellent peer relations.
Ability to effectively present complex data and strategy to large groups.
Accomplishes results through the management of a team of professional employees and/or managers and other leaders.
Acts as an advisor to subordinate supervisors or staff members.
Develops and administers budgets, schedules, objectives, and goals.
Independently determines approach to managing teams and daily operations.
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.
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.
Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
Understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Nice To Haves

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

Responsibilities

Ensuring the quality of licensed and clinical products manufactured at the facility.
Overseeing teams focused on quality oversight of day-to-day site operations, raw material release and drug substance lot disposition.
Providing leadership and guidance to other functional areas in areas of regulatory compliance, quality practices, and quality systems.
Communicating company goals, safety practices, and deadlines to the team.
Motivating team members, providing guidance and leadership, assessing performance, and helping with the development of direct reports.
Reviewing and understanding analytical data.
Building action plans, problem solving and decision making in a timely manner for on-budget, on-time objectives.
Identifying and creatively resolving complex problems at a site-level through good decision making utilizing functional and broad-based technical skills and leadership capability.
Managing conflict and standing alone on issues.
Providing constructive feedback to staff.
Developing strategic initiatives and assisting in translating them into tactical solutions.
Developing strategy and negotiating senior management approval.
Determining and establishing organizational structures and supervisory relationships, subject to top management approval.
Representing the organization unit as prime internal and external contracts or operations.
Conducting briefings and technical meetings for top management and customer representatives.
Interacting with top level-level managers concerning matters of significance to business and product quality to ensure customer expectations are met.
Accomplishing results through the management of a team of professional employees and/or managers and other leaders.
Acting as an advisor to subordinate supervisors or staff members.
Developing and administering budgets, schedules, objectives, and goals.
Independently determining approach to managing teams and daily operations.
Conducting activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.
Completing all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
Reporting potential issues of non-compliance.
Ensuring and monitoring 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.
Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
Understanding the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.