Global Qc Lead

Are you ready for an opportunity to join AstraZeneca in a lead role with a focus on leading the deployment and integration of enhanced control strategies for continuous manufacturing? Are you seeking a leadership opportunity to push the boundaries of science, transforming our operation to the factory of the future which incorporates advanced analytical capabilities in process analytical technology (PAT) and predictive methods of analysis, and growing our science and technology capabilities?_

Our **Gaithersburg, Maryland** facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

We are looking for a talented **Global QC Lead - Process Analytical Technology (PAT)**, to strengthen our capabilities in the area of **analytical science** towards **control strategies developed using an enhanced approach**. If you believe that you have operations Quality and manufacturing knowledge based in science then join us in our **Global Quality & Stability** **organization** This role will have global responsibilities and can be based at our site in** Sweden or globally.**

Here at Global Quality & Stability, we work at the forefront of advanced technologies and digitalization with a focus on delivering high quality medicines to our patients leveraging our talented and diverse global team. We are always looking for creative and innovate ways to ensure we can consistently meet our patient’s needs.

Our organization, The Global Quality & Stability group owns, the delivery of Global Quality Control Strategy to improve and sustain the Global QC operation with processes to enable efficient delivery of safe and effective medicines to patients. We proactively integrates quality into our supply chain advancing beyond our compliance license to operate. We are accountable for the following areas:
Global Quality Control

Global Stability

Global Microbiology

Global Materials Certification

**What you’ll do**

The role will deliver on the following objectives:

- Application of PAT to capitalize on product lifecycle management opportunities.
- Identification of manufacturing process monitoring step data and correlated to QC results, that can be used for regulatory submissions and business cases for change
- Product launch considerations with PAT from development through to regulatory submission
- Lead time improvements associated with PAT control and NPI launches
- Industry benchmarking and external advocacy position papers
- Serve as an expert/leader within Global Quality & Stability Organization, mentor colleagues in the area of enhanced control strategies and Process Analytical Technology (PAT), operationalizing our PAT Strategy transforming our business.
- Provide direction and advice on new science and technology within Quality Operations of enhanced control strategies with PAT, to take part in tech transfer of these advanced analytical methods.
- Continue to drive scientific excellence in the area of process analytical technology and advanced process control methodologies and technologies within the company. Provide leadership, coaching and mentorship to the QC Network other cross-functional colleagues.

**Essential for the role**

**Qualifications for this role include**:

- Holds a minimum of Degree level in Pure or Applied Science (e.g., Biology, Chemistry, Pharmacy, Chemical Engineering) or other relevant scientific discipline and experience.
- A minimum of 10 years’ experience in the pharmaceutical / bio-pharmaceutical industry, including having direct site experience in Quality and GMP associated with the manufacture of Drug Product or Drug Substance.
- Sound knowledge and understanding of the principles and concepts of GMP, quality and compliance management, quality risk management and performance evaluation and control.

**Desirable for the role**
- Demonstrated delivery of process analytical technology including advanced process control/MVDA, model predictive controls in support of pharmaceutical continuous processing. Well versed in ICH Q8, Q9, Q10, Q11 and Q13 guidance’s, Quality by Design principles, implementation of enhanced approaches for project/product specific control strategies.
- Experience in technology transfer and commercial ma