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Scientific Quality Investigator

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United Kingdom  United Kingdom
Culture/Humanities, English

Job Description:

Scientific Quality Investigator

The purpose of this position is to ensure that In Vivo In Vitro Translation (IVIVT) operations are in a compliant state with respect to (COMPANY NAME) policies/procedures and regulatory regulations. The role covers a wide scope of operational quality and compliance responsibilities, from discovery research through to clinical studies. The job holder will work effectively in a matrix across IVIVT business functions to ensure that quality and compliance requirements are clearly identified and understood, risks are proactively managed and mitigated, and best practices established. The job holder will partner with the business to identify and manage inherent and emerging IVIVT risks which individually or collectively influence the achievement of our strategic goals and protect our license to operate.

At (COMPANY NAME), we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New (COMPANY NAME) with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New (COMPANY NAME), this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new (COMPANY NAME) where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

Key Responsibilities include, but are not limited to:
This role will provide the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
* Provide the required expertise in the delivery of operational quality and risk management, leading through matrix teams across IVIVT.
* Leads/facilitates/participates in projects to deliver improvements to the clinical laboratory Quality Management System through collaboration with R&D.
* Understand the business needs of IVIVT departments, with respect to technology infrastructure, third party work and human biological sample management by developing strong working relationships in order to develop best practices and complaint processes to ensure Regulatory Compliance and maximize the business impact of investments in IVIVT for pipeline impact and technology innovation.
* Act as the single point of contact for Scientific Quality to support IVIVT Systems group and scientific staff to define best Quality practices to be compliant with equipment, data generation and data flow in IVIVT
* Act as the single point of contact for the Scientific Quality to support the BIB UK Facility Quality and Compliance inquiries and process improvements
* Act as single point of contact for Scientific Quality to support BESM, TESM and scientific staff to define the best practices to be compliant with Third Party Oversight work.
* Author and review IVIVT written standard proposals and written standards which have IVIVT scope, as required. Facilitate applicable training and development programs.
* Serve as a contact during regulatory inspections. Lead and participate in internal/external audits and facilitate responses to audit findings. Ensure that deficiencies are addressed, and learning is shared.
* Contribute to the building of a compliance culture through the design and delivery of engagement communications, training, and activities within IVIVT.
* Encourage a culture of self-reporting and raising concerns, quality incidents, and near-misses are raised without hesitation throughout the organization.

Closing Date for Applications: Thursday 27th January 2022

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0xxx xxx xxx1. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor or MS degree from a scientific or related discipline with experience of pharmaceutical industry experience.
* Experience working in the regulated preclinical and clinical space with a deep knowledge of regulatory guidelines (GxP) from health authorities such as the US FDA and EMA.
* Capability to manage complex projects, coordinate demands and timelines, influence stakeholders, manage expectations and align project strategies among stakeholders.
* Experience working on cross-functional drug development teams and driving/delivering pipeline strategies and commitments to study teams in a matrix environment.
* Experience in scientific/technical subject(s) and a proven working knowledge across the breadth of quality and compliance: quality systems, change control, business continuity, root cause analysis, and risk management
* Experience in delivering outcomes through a matrix environment and able to be transparent, resolve conflict, and positively influence situations to achieve a desired outcome through a high degree of personal effectiveness.
* Knowledge of essential regulatory guidelines world-wide and (COMPANY NAME) company policies and procedures e.g. detailed knowledge of (COMPANY NAME) SOPs, ICH and FDA regulations as they impact all aspects of drug development
* Awareness of or experience in preclinical and clinical space in a pharmaceutical or biotech R&D environment or leading academic research center.
* Strong written/verbal communication skills and the demonstrated ability to work in a matrix and effectively collaborate with internal and external groups
* Experience to deliver outcomes through a matrix environment and able to be transparent, resolve conflict, and positively influence situations to achieve a desired outcome through a high degree of personal effectiveness

(COMPANY NAME) is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside (COMPANY NAME); in the way we do business; and in the communities where we operate. 
We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at (COMPANY NAME) bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0xxx xxx xxx1, or send an email uxxxxxxxxxx.xxxxxxxxxxx@xxx.xxm

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

(COMPANY NAME) does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of (COMPANY NAME). (COMPANY NAME) shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site

Source: Company website
Posted on: 15 Jan 2022
Industry: Health Care
Languages: English
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