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Quality Operations Director


Floresville, TX 78114
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Job Details

Ringaskiddy API Site's role in the API Network is to support all Small molecule new product launches, scale up and commercialize new products and manufacture in-line API for Pfizer products.

The Ringaskiddy vision is to be a dynamic, flexible, innovative community partnering to deliver technical excellence and value, trusted to continuously improve and supply quality, life-changing medicines. To deliver this vision the Site is on a transformation journey. To achieve a step-change in productivity, performance and cost effectiveness, the Site Leadership Team will visibly lead the site by setting & delivering ambitious targets on supply, quality, safety and cost in order to achieve the vision and position Ringaskiddy as a competitive and flexible site.

The **Quality Operations Lead** role is a key strategic part of this Leadership team. The Quality Leader will deliver Quality Excellence in partnership with the site goals of cost competiveness and supply reliability; ensuring a strong Quality and performance culture for site focusing individual contribution, RFT and continuous improvement.

The Site **Quality Operations Leader** is responsible for providing strategy and leadership in assuring that appropriate Quality systems and processes are in place to meet or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors. This position has a dual reporting relationship, both to the Site Leader and to the VP API Quality Operations. T he Site Quality Operations Leader will be a member of both Leadership Teams.

Key focus areas and responsibilities for this position include:

Overseeing all Quality Operations functions and Site Quality Review Team (SQRT); Optimising all elements of quality operations, in particular delivering on continuous improvement initiatives in QA and QC operations; planning, implementing and achieving site Quality Operations objectives consistent with Site Objectives and Global Quality Operations objectives;

Providing leadership, development and direction to the Quality Operations team; interfacing with global regulatory agencies.

The Site Quality Operations Leader will lead, manage and develop a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support and guidance to all operations at the site in assuring Pfizer's Quality Standards are met.


1. Quality Product and Compliance: Ensure all product is manufactured, tested and released in compliance with ICHQ7a and Pfizer requirements:

Oversight of all GMP areas to assure compliance with regulatory standards

Lead site regulatory audits including PAI inspection

Support functions to comply with quality standards

2. Quality Culture / CI: Partner with functions to develop and promote a strong quality culture focussed on RFT, CI and individual accountability

Drive continuous improvement through SQRT process, holding all functions to account

Reduce HE deviations to Zero

Investigate deviations / CAPAs within the agreed timeframe

3. Batch release (supply): Responsible for batch test and release lead time enabling on time production and shipping

Deliver on continuous improvement programs in QA and QC operations to meet supply and compliance requirements.

Enable test and release adherence to the planned production and shipping schedule

Deliver on target batch test and release times

4. Support New Product Launches and 2nd Generation filings

Provide Quality support to ensure successful New Product launch

Support Value Streams to deliver 2nd Generation products on site

5. Cost: Deliver all quality activities within budget and within target headcount

Improve productivity, efficiency and cost effectiveness of quality function

6. Safety: Responsible for adherence of quality function to safety standards

**Qualifications (Training, Education & Prior Experience):**

+ Bachelor, Master's Degree and / or PhD in Science

+ Minimum 15 years of relevant experience, including 10 years' leadership experience in the pharmaceuticals industries, performing manufacturing, technical services, research or QA functions

+ Minimum 5 years QA or QC related experience and 3 years of Quality leadership experience is preferred

+ Demonstrated knowledge of GMPs, Lean RFT and Operational excellence tools, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills

+ Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives

+ A proven communicator and ability to deliver team performance in adherence to the fundamentals of safety, quality cost, and supply.

+ Be a strategic influencer and change agent, the role requires significant leadership skills and proven ability to involve several levels of an organization to successfully meet the objectives.

+ Shows fresh, insightful thinking by developing creative approaches to processes and practices, products and solutions, services, business models and strategies

+ Deliver a Culture of People Excellence; supporting individual development to maximise each colleagues potential, and recognising individual and team performance through full use of available processes including mission awards, site communications and individual recognition.

+ Experience working with complex organizational and ability to work across functions and with all levels of the organization where the incumbent may not have direct authority.

+ Must have a successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing. Thorough knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products is required. Experience in API operations is highly desirable.

Pfizer Behaviours/Core Competencies

Acts Decisively.

Seizes Accountability.

Holds People Accountable.

Builds Effective Teams.

Grows Self /Others.

Self Awareness.

Commits to "One Pfizer".

Closing date for applications is Friday 6th April 2018

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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