Associate Director, External Quality

Introduction to role

Are you ready to take on a pivotal role in ensuring the highest standards of quality for life-changing medicines? As the Associate Director, External Quality, you will be responsible for leading the Quality of assigned External Suppliers within various categories including API, DS, Cell Bank, Formulation & Packing (F&P), Vaccine, and Critical Material Supplier (CMS). Your role will encompass a wide range of Quality activities, from leading all aspects of Quality Systems to running product releases and regulatory interactions. You will work cross-functionally with various teams to ensure that our suppliers meet the quality standards required to deliver safe and effective products to patients. (locations include: Gaithersburg, MD, Coppell, TX, Wilmington, DE, Mt. Vernon, IN)

Accountabilities

• Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings.

• Maintains a level of understanding of relevant production processes and quality systems.

• Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers:

• Change Requests
• Product Quality Reviews or Supplier Quality Review (DMS)
• CMC documentation (ERV) associated with changes or product establishment at Suppliers
• Development and technology transfer documentation, along with Director, Supply and Quality Systems, EQ
• Quality Investigations (Deviations, Product Quality Complaints)
• Validation Plans, Protocols and Reports

• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.

• Resolve quality issues related to customer concerns at Suppliers for timely product deliveries.

• Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).

• As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s).

• Collaborates with, and influences, other PCO/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative efficient and effective practices.

• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to EQ/AZ site leaders.

• Collaborates in data analysis and report creation on quality metrics and key performance indicators.

• Develops and maintains effective business relationships with Suppliers.

• Specific to the support and management of External Quality QMS, may be responsible for one or more of the following:

• Site Stability Management System.
• Handles quality data and records in relevant quality management support systems (e.g. Veeva Vault etc) as the need arises.
• Assist in the production of, or contribution to, AZ quality documentation (including EQ/EQ SOPs, Q & C Manual Procedures, etc)
• Participates in EQ self-inspection program, auditing processes and procedures.

  • Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the External Supply & Manufacturing (ESM) and External Quality (EQ) organisations.

• Accountable for Quality decision-making; works directly with the Supplier Management leader and other team members to deliver objectives.
• Ensures compliance with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management Team.
• Provides functional direction as the need arises.

• Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites).

• As needed, perform Quality Audits within their technology area, as a Guest Auditor on the GQA lead audit team.

• Serve as EQ representative on Issue Management Teams.

• Provide experienced Quality input to NPI, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Supplier’s way of working with External Quality and supporting the Supplier through to regulatory approval.

• Liaise with Suppliers to ensure successful delivery of projects.

• Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.

Essential Skills/Experience

• Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country).

• Minimum of 8 years if relevant experience (experience in Quality Assurance or combination of Quality and Technical)

• Shown broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role

• Strong proven knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.

• Excellent oral and written communication skills [English and local language(s)]

• Proven experience working cross functionally and leading significant improvement initiatives (e.g. project management skills)

• Strong problem-solving skills

• Strong negotiating/influencing skills

• Ability to work independently under their own initiative.

• Ability to travel nationally and internationally as the need arises up to 25% of their time.

Desirable Skills/Experience

• Experience working in a PCO/PET organization or Lean/Six Sigma training.

• Multi-site / multi-functional experience

• Shown experience in Quality Assurance or combination of Quality and Technical

• Master’s degree in Quality Assurance/Regulatory Affairs or other advanced scientific field

When we put unexpected teams in the same room, we unleash ambitious 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.

At AstraZeneca, we are driven by a passion for science that leads us to innovate continuously. Our commitment to excellence means we are always looking for ways to improve outcomes for patients. Here you will find an environment that values your contributions, encourages collaboration, and supports your professional growth.

Ready to make a difference? Apply now!

The annual base pay for this position ranges from $155,126 to  $186,150. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 authorisation and employment eligibility verification requirements.