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Senior Manager, R&D Quality - Allergan Biologics Ltd.

Posted: 2 May 2018

Closing: 1 June 2018


This position is responsible for application of global Quality Assurance operational activities that balance patient safety, domestic and international regulatory requirements and Allergan Quality Assurance standards, with clinical supply needs, corporate and development milestones and commercial product launch timelines to biological CMC projects.

The role interacts with all Global Teams to verify that Chemistry, Manufacturing, and Controls activities are in alignment with Clinical, Non-Clinical and Regulatory Affairs efforts in support of product development and launch. This position is also responsible for supporting operational activities and requirements for all new biological product candidates, ensuring critical patient safety parameters are met while minimizing time from discovery to clinic based on sound regulatory risk management and mitigation.

This position is also responsible for the management of Liverpool based CMC QA leads for biological products (Managers, R&D Quality).

As well as internal stakeholder interactions, this role will also interact with external stakeholders such as development partners, contract manufacturing or laboratory organizations and regulatory authorities.

Key Responsibilities:

Act as CMC QA lead for biological product development projects:
Establishes quality strategies to rapidly accommodate the movement of development projects through pre-Clinical, Clinical and Technology Transferactivities.
Employs appropriate risk management strategies to minimize timelines without compromising patientsafety.
Provides guidanceto global teams on quality aspects of biological product candidates.
Represents Qualityon CMC teams that deliver new biological product candidates clinic following internal policies and regulatory requirements and standards.
Works with other area of PDQA to harmonize diverse development group efforts such as biologics/device.
Manage Liverpool based CMC QA leads for biological products (Managers, R&D Quality)
Provide quality oversight for complex development supply chains encompassing internal and external suppliers of raw materials, drug substance and drug product manufacture and testing related to clinical trial supplies
Working with other CMC QA leads for biological products, establish and coordinate project milestone plans across all biological projects for reporting to PDQA leadership team.
Establish project review forums with other CMC QA Leads for biological products to enable sharing of project knowledge between CMC QA Leads for both drug substance and drug product supply.
Mentor and support other CMC project leads
Build relationships with key stakeholders e.g R&D, Operations, Reg Affairs
 
Qualifications, Skills and Experience:

Excellent written, verbal,and analytical skills are essential.
Proven ability to lead, influence and manage people with diverse technical backgrounds within a matrix organisation
Proven ability to implement and train employees on key quality system elements.
Ability to managemultiple and complex activities or projects.
Must be able to negotiate effectively, especially between competing projects and/or resources. Must be able to craft creative solutions to difficult situations quickly.
Must have the ability to defend quality principles, frequently to senior management, even, if business objectives may not be met.
Proven knowledge and experience in pharmaceutical product validation procedures.
Proven ability or project management experience in the pharmaceutical industry.
Proven ability to manage people/projects to accomplish a common goal.
Ability to influence individuals that are outside the span of direct control(i.e., influence without authority).
Must have excellent organisation skills.
Extensive experience within a Pharmaceutical R&D or commercial environment with a bachelor's degree or equivalent in Biology, Chemistry or Health Related Science.
Significant experience in pharmaceutical Quality Assurance, including some experience in a supervisory or management position.
Knowledge of diverse domestic and international regulatory requirements and technical standards for drugs, specifically including manufacture of biologics, product development, testing and distribution.
Extensive experience in quality systems, quality methods, statistics, product qualification/validation, and a basic understanding of clinical product supply requirement.

Behaviours – linked to the Allergan BOLD culture:
 
We Build Bridges with each other, customers and partners
You will build effective relationships with internal and external parties.  You will demonstrate awareness of the impact of your work upon other teams and projects and work to remove barriers.  You will be comfortable in your ability to deliver clear communications to both internal and external customers and be aware of your personal impact. You will foster collaboration by promoting knowledge sharing and team working. You will be able to adapt the message and style to suit the audience.
 
We Power Ideas that change healthcare
You will demonstrate and effectively communicate sound opinion to influence project outcomes.  You will question the robustness of your and others work and investigations along with the validity of conclusions drawn.  You will demonstrate your initiative on a day to day basis by challenging the status quo, proposing and delivering new solutions to drive continuous improvement and create value for the business. You will see change as an opportunity to develop.
 
We Act Fast to be responsive to customers and business opportunities
You will adapt to changing demands with agility and be action oriented to overcome challenges.  You will apply strong problem solving skills to resolve issues and seek simple solutions.  You will make quality decisions on outcomes. 
 
We Drive Results and execute our plans
You will take ownership of your work and others to deliver the programme or project.  You will be seen as a valuable influencer of change and demonstrate a positive attitude at all times.  You strive to be the best and make a difference every day.

For details on how to apply for this position please visit:
https://agn.referrals.selectminds.com/default1017/jobs/sr-mgr-r-d-quality-5223