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QA Manager and QP at Sandoz
london, London - England, United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

14 Jan, 27

Salary

95000.0

Posted On

16 Oct, 26

Experience

20 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

About the job

Arcinova, A Quotient Sciences Company, is dedicated to providing innovative contract research, development, and manufacturing services. We offer a comprehensive range of integrated specialist services for early stage drug development, underpinned by strong industry knowledge and scientific expertise.


Our mission is to bring science, innovation, and collaboration together to overcome the barriers in drug development. We empower emerging biotechs and large pharma alike to bring life-changing therapies to patients faster, through an efficient, effective approach focused on quality, science, and innovation.


Our vision is to advance progress through science, delivering solutions that make a measurable difference. We look ahead with purpose, driven to shape a smarter, more resilient future for all.


The Role


Arcinova, a Quotient Sciences company, is seeking a Head of Drug Product to lead our Drug Product Manufacturing and Formulation Development teams based at our Alnwick site.


In this role, you will lead, engage, develop and coach teams of manufacturing and formulation scientists to ensure the successful delivery of customer projects. Working closely with global leaders, you will support the delivery of the Drug Product operational strategy and wider business objectives, while developing and maintaining operational capacity plans that underpin future growth and investment decisions.


You will be responsible for ensuring Drug Product operations are conducted in compliance with relevant GxP guidelines and regulations, while driving operational performance, customer satisfaction and commercial success. This is a key leadership position with responsibility for ensuring Quotient delivers the right services to the right customers at the appropriate price, supporting the achievement of the site's financial and strategic objectives.


Main Tasks And Responsibilities


People and Culture


  • Achieve high levels of performance and engagement through inspirational and authentic leadership, coaching and mentoring of the Drug Product Operations team.
  • Develop robust talent and succession pipelines to develop and retain key talent and deliver business objectives.
  • Ensure adequate recruitment, training and employee development is in place to maintain a highly motivated, skilled and effective workforce, ensuring the needs of the business are met.
  • Ensure Quotient's manifesto, behaviors and 'The Quotientness of Quotient' (Science, Agility and Culture) is embedded, lived and evolved.
  • Create a collaborative, inclusive and engaging culture where everyone has the opportunity to achieve their potential and develop their career within Quotient.

Strategy Setting and Deployment


  • Work closely with Global and Local leaders to deliver Quotient's operational strategy and operational business objectives.
  • Develop and deliver the yearly financial target for Drug Product Operations including Revenue, EBITDA and Capital expenditure.
  • Stay ahead of market developments, anticipate challenges and adapt business plans appropriately.

Technical Leadership


  • Lead the strategic operational projects within DP Operations.
  • Provide technical, scientific and administrative support to, and manage a team of scientists engaged in formulation development and Drug Product Manufacture.
  • For GLP studies perform the role of Study Director or Principal Investigator.

Customers / Commercial


  • Build and maintain strong relationships with customers by developing and implementing integrated operational delivery offerings to ensure Quotient remains competitive in commercial landscape, and ensure first class operational delivery and service.
  • Drive harmonization activities to ensure a one business, one experience for customers.
  • Engage with Business Development and commercial teams to support new project opportunities and triage appropriately.

Operational Excellence


  • Drive continuous improvements throughout Drug Product operations to deliver efficiencies and enhanced compliance standards.
  • Develop, maintain and visualize monthly metrics to demonstrate continuous improvement.

Compliance


  • Work with the People, Compliance, EHS, IT and Facilities functions to ensure all activities are conducted in line with the necessary health & safety, legal, financial, quality and external guidelines and SOP’s and the site and functional objectives are met.
  • Keep abreast of regulatory changes and ensure Quotient processes remain compliant with emerging regulatory needs.
  • Support the conduct of client audits and those from regulatory agencies. Bringing wider regulatory/local system knowledge to bear.

Qualifications And Experience Required For Competent Performance


  • BSc (Hons) or equivalent in a relevant scientific discipline.
  • Experienced working with customers, commercial, finance, HR and compliance teams.
  • Experienced leader of technical staff.
  • Extensive knowledge and experience of pharmaceutical GMP formulation development and Drug Product manufacturing.
  • Experience of Steriles manufacture process and procedures.
  • Experience of GMP/GLP regulations and requirements.
  • Excellent written and oral communication skills.
  • Have a flexible approach to new work challenges.

Application Requirements


When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.


Our Commitment to Diversity, Equity and Inclusion


Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.


Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.


This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.


Our Approach to AI in Recruitment


At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.


While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.


  • We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.

How To Apply:

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Responsibilities

About the job

Arcinova, A Quotient Sciences Company, is dedicated to providing innovative contract research, development, and manufacturing services. We offer a comprehensive range of integrated specialist services for early stage drug development, underpinned by strong industry knowledge and scientific expertise.


Our mission is to bring science, innovation, and collaboration together to overcome the barriers in drug development. We empower emerging biotechs and large pharma alike to bring life-changing therapies to patients faster, through an efficient, effective approach focused on quality, science, and innovation.


Our vision is to advance progress through science, delivering solutions that make a measurable difference. We look ahead with purpose, driven to shape a smarter, more resilient future for all.


The Role


Arcinova, a Quotient Sciences company, is seeking a Head of Drug Product to lead our Drug Product Manufacturing and Formulation Development teams based at our Alnwick site.


In this role, you will lead, engage, develop and coach teams of manufacturing and formulation scientists to ensure the successful delivery of customer projects. Working closely with global leaders, you will support the delivery of the Drug Product operational strategy and wider business objectives, while developing and maintaining operational capacity plans that underpin future growth and investment decisions.


You will be responsible for ensuring Drug Product operations are conducted in compliance with relevant GxP guidelines and regulations, while driving operational performance, customer satisfaction and commercial success. This is a key leadership position with responsibility for ensuring Quotient delivers the right services to the right customers at the appropriate price, supporting the achievement of the site's financial and strategic objectives.


Main Tasks And Responsibilities


People and Culture


  • Achieve high levels of performance and engagement through inspirational and authentic leadership, coaching and mentoring of the Drug Product Operations team.
  • Develop robust talent and succession pipelines to develop and retain key talent and deliver business objectives.
  • Ensure adequate recruitment, training and employee development is in place to maintain a highly motivated, skilled and effective workforce, ensuring the needs of the business are met.
  • Ensure Quotient's manifesto, behaviors and 'The Quotientness of Quotient' (Science, Agility and Culture) is embedded, lived and evolved.
  • Create a collaborative, inclusive and engaging culture where everyone has the opportunity to achieve their potential and develop their career within Quotient.

Strategy Setting and Deployment


  • Work closely with Global and Local leaders to deliver Quotient's operational strategy and operational business objectives.
  • Develop and deliver the yearly financial target for Drug Product Operations including Revenue, EBITDA and Capital expenditure.
  • Stay ahead of market developments, anticipate challenges and adapt business plans appropriately.

Technical Leadership


  • Lead the strategic operational projects within DP Operations.
  • Provide technical, scientific and administrative support to, and manage a team of scientists engaged in formulation development and Drug Product Manufacture.
  • For GLP studies perform the role of Study Director or Principal Investigator.

Customers / Commercial


  • Build and maintain strong relationships with customers by developing and implementing integrated operational delivery offerings to ensure Quotient remains competitive in commercial landscape, and ensure first class operational delivery and service.
  • Drive harmonization activities to ensure a one business, one experience for customers.
  • Engage with Business Development and commercial teams to support new project opportunities and triage appropriately.

Operational Excellence


  • Drive continuous improvements throughout Drug Product operations to deliver efficiencies and enhanced compliance standards.
  • Develop, maintain and visualize monthly metrics to demonstrate continuous improvement.

Compliance


  • Work with the People, Compliance, EHS, IT and Facilities functions to ensure all activities are conducted in line with the necessary health & safety, legal, financial, quality and external guidelines and SOP’s and the site and functional objectives are met.
  • Keep abreast of regulatory changes and ensure Quotient processes remain compliant with emerging regulatory needs.
  • Support the conduct of client audits and those from regulatory agencies. Bringing wider regulatory/local system knowledge to bear.

Qualifications And Experience Required For Competent Performance


  • BSc (Hons) or equivalent in a relevant scientific discipline.
  • Experienced working with customers, commercial, finance, HR and compliance teams.
  • Experienced leader of technical staff.
  • Extensive knowledge and experience of pharmaceutical GMP formulation development and Drug Product manufacturing.
  • Experience of Steriles manufacture process and procedures.
  • Experience of GMP/GLP regulations and requirements.
  • Excellent written and oral communication skills.
  • Have a flexible approach to new work challenges.

Application Requirements


When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.


Our Commitment to Diversity, Equity and Inclusion


Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.


Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.


This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.


Our Approach to AI in Recruitment


At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.


While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.


  • We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.