Software Quality Assurance Director jobs in Maryland

Are you ready to foster an attitude of excellence? Join AstraZeneca's Operations team as the Associate Director of Quality Engineering. In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Rockville Manufacturing Center (RMC) facility. This includes Quality Review and Approval for including Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, Reports, as well as leading the technical quality arm of the Quality department. You will also have responsibilities over resource planning, shift structure design, and organizational assignments. You will lead and develop people focusing on planning, communication, leadership, teamwork, problem-solving, performance management, and talent development. You will also ensure that operations are aligned with the cGMP standards established by AstraZeneca and relevant regulatory agencies.

Accountabilities:

As the Associate Director of Quality Engineering, you will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the quality and manufacturing objectives in support of site goals. You will represent the QE department and/or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives. You will facilitate the growth and development of QE staff, provide strategic support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels.

Essential Skills/Experience:

- B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 8 years of applicable experience

- M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

- Minimum of 2 years of Cell Therapy/Biologics Quality Engineering experience

- Minimum of 2 years of management/supervisory/project management experience preferred

- Experience with product launches, health authority inspections, and global commercial product distribution requirements

- Proven track record of working in a fast-paced environment across multiple technical functions.

- Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.

- Ability to influence senior collaborators, both internally and externally

Desirable Skills/Experience:

- Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

- Demonstrated track record in leadership of organizational change in a positive and non-disruptive manner to the company’s values.

- Experience with Cell Therapy regulatory inspections

- Experience engaging with global regulatory bodies.

- Consistent track record of attracting and developing talent.

- Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca, we take Quality seriously. Our work is important and valued, and we're backed by a belief that good can always be better. We search for opportunities to add value, harnessing science and evidence to foresee risk. We continuously innovate to find new and better ways to ensure we are improving outcomes for patients. We are a team of ambitious people, who want to go far and we're all here to achieve. It's what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes.

Ready to join an environment of excellence? Apply now and let's make a difference together!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.