Associate Quality Directors - Gaithersburg, MD | Biospace
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Associate Quality Directors

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/20/2017
Position Type:
Full time
Job Code:
R-012133
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location: Macclesfield,
England,
United Kingdom
Södertälje,
Stockholm,
Sweden
Gaithersburg,
Maryland,
United States
Wilmington,
England,
United Kingdom
Job reference: R-012133

Posted date: Aug. 07, 2017



Associate Quality Director – Global Supplier Quality

Positions available in Europe (UK or Sweden) and America

At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

How do you spot the potential for something world-changing? With bold, empowered people and leaders who champion curiosity – and the fearlessness to pursue ideas in new ways.

The new Global Supplier Quality (GSQ) organisation is an evolution of the GES Quality team, combining global and local supplier management across the AstraZeneca Operations network. The organisation has been created in response to the Operations 2020 strategy and Operations Quality 4S – Simplify, Standardise, Share and Sustain. This allows us to share operations best practice, reduce supplier management compliance risks and drive value by capitalising on synergies.

GSQ will provide Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations and will launch in January 2018. The scope of the organisation includes outsourced API, Biologics CMOs, Direct Materials, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.

The new Associate Quality Director roles in Europe and USA reflect the increased scope of the GSQ organisation and helps manage the span of control and staff development options within each group.

Responsibilities:

As an Associate Quality Director you will work closely with Quality Directors and Senior Quality Supplier Managers to support the performance of required Quality System activities for Global Supplier Quality (GSQ). You will hold responsibility for Quality activities that support execution of Quality Management of Suppliers.

Your responsibilities will include line management and Quality System performance of the following activities: change control, product quality complaint and deviation investigations, quality issue management and escalation, certification reports, QA Agreements (establishment and maintenance) between AZ and External Suppliers and between GES and AZ Operations Sites and (for the AQD/QP - QP certification of product on the AZAB GES License). In addition, you will be involved in the preparation and submission of periodic Supplier Quality Assessments and performance of Regulatory Agency interactions as needed. Regulatory Agency interaction includes assisting in the preparation for and management of Regulatory Agency inspections at External Suppliers and AZ Sites (when external suppliers are within the inspection’s scope), license updates and notification of product issues.

Within the Global Supplier Quality (GSQ) organization you will hold responsibility for the oversight and ownership of Quality System(s). These will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories or Quality System elements.

In addition, the preparation and submission of periodic Supplier Quality Assessments, Regulatory Agency interactions and serving as Quality leaders on NPI, new supplier introductions, In Licensing, strategic sourcing projects, process optimization and product transfer projects, as these relate to Quality Supplier management, are within the scope of activities you will be involved with. Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections at External Suppliers and AZ sites (when External Suppliers are assessed).

Requirements

Essential Requirements:

You will hold a Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering. Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role.

For roles based within Europe (if acting in AQD-QP role, you should be a fully qualified QP) or qualified- Pharmacist, or Masters Degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering, (and for AQD-QP, complying with educational requirements as defined in LVFS 2004:7, §7 is required). You should also have proven experience in either pharmaceutical operations environment or pharmaceutical Quality Assurance role for at least 2 years.

You should have strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment along with a strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.

Possessing excellent oral and written communication skills you will also be able to demonstrate strong negotiation and influencing skills.

You should be able to demonstrate experience of working cross-functionally and managing significant improvement initiatives (e.g. project management skills) as well as demonstrating strong problem solving skills.

For these roles you should have the ability to travel nationally and internationally as required approximately 25% of their time.

Closing date for applications:
Midnight Friday 8th September 2017

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.