Compliance Specialist / Sr. Compliance Specialist - Newark, De - Global Operations

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Compliance Specialist in Newark,DE,
Shift:

• Days: Monday to Friday schedule (4 days a week, 9 hours a day)

• Hours: 1st Shift

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of sophisticated products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities. It's important to us that you bring your full self to work every day. To help maintain your best self, here's a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The core responsibilities of the role are as follows:

• Manage all Compliance programs and lead/execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies.
• Provide oversight/process ownership for core Quality Systems including but not limited to; Complaints, Quality Events / Deviations, CAPA, Change Control, Product Reviews, Supplier Quality, Internal Audit Program, and other Quality Systems as needed to support the site.
• Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current Compliance requirements and influencing key stakeholders on recommended Compliance improvements.
• Host/lead/manage inspections of site by External Customers, internal assessors, and Regulatory authorities.
• Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world - 20% of our global workforce. With 30 production facilities in 18 countries we're focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that's full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

Qualifications:
Education:

• Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering

Required:

• Minimum of five years experience in the pharmaceutical industry and/or FDA experience and minimum 3 years in Quality Assurance/Compliance.
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices
• Strong familiarity with production operations.
• Strong leadership, project management, and technical writing.

Desired:

• Minimum of seven (7) years in QA/Regulatory Compliance in the pharmaceutical industry.
• Prior experience leading/managing regulatory inspections.
• Experience managing Quality Systems
• ASQ certifications (e.g. CQA, CQE, CQM).
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.

Date Posted
05-Feb-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.