Manager, QA Operations

Title:

Manager, QA Operations

Company:

Ipsen Biopharmaceuticals Inc.

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Part of Global Quality organization and Partner of the Research & Development and Global Medical Affairs (including interfaces) you are a key contributor of the clinical & Medical QA organization, you are accountable for ensuring a compliant state of the clinical studies/programs managed by IPSEN R&D and Global Medical Affairs across Therapeutic Areas; as well as ensuring clinical and medical quality activities are effective, executed and maintained in compliance with the applicable regulations and Ipsen standards. You will act as the Quality point of contact/key partner for clinical teams for the studies assigned including interface functions. In this position, you will also conduct Quality-related activities for the clinical studies assigned, and ensure consistency and standardization in operational methodology and processes. Additionally, this position supports related integration process in the Therapeutic Area.

Main Responsibilities & Technical Competencies

Clinical Studies/Programs:

• For the clinical studies/programs assigned, works with the clinical and medical teams to ensure good clinical practices and relevant regulatory requirements are met.
• Ensure quality oversight of the clinical studies and programs within their remit and ensure consistency and standardization in operational methodology and processes in their management.
• Act as a key partner for to cross functional study teams, to provide quality assurance expertise and guidance
• Monitor quality performance of the clinical studies/programs: data collection, targets definition, best practices promotion, improvement initiatives, and appropriate reporting.
• Escalate systemic problems and appropriate recommendations/solutions to management for immediate and long-term resolution
• Reviews contracts with clinical vendors and partners to ensure compliance responsibilities are included
• Other assignments as directed by QA management (e.g.: New projects)
• Support the preparation of the clinical quality plan including analysis
• Ensure quality of the clinical studies/programs initiated by the local (affiliate) as per a risk-based approach
• Ensure timely assistance for quality related topics.
• Support Service Provider QA Operations in the quality oversight of SP activities.
• Escalate to Manager identified issues that need to be discussed during the oversight and/or steering committee

Due Diligence/Integration activities:

• Contribute to integration process in collaboration with CM Quality System
• Provide clinical quality related input to business functions

Maintain a Robust Clinical and Medical QMS:

• Support and facilitates implementation and continuous improvement for clinical quality and operational processes.
• Ensure proper management including documentation, investigation, and CAPA definition of major/critical Quality Events and potential Serious Breaches in GCP.
• Monitor the clinical regulatory environment to ensure the continued compliance of the quality system and subsequent implementation plans.
• Contribute to development of plans for quality documentation related activities.
• Contribute to training sessions as SME, by reviewing training materials or participating in presentations.
• Perform Risk Assessment and ensures communication to management and documentation in eQMS.
• Foster a culture of continuous process improvement by monitoring CAPA effectiveness and facilitating Quality Risk Management activities.
• Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed.
• Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary.

Compliance activities:

• Quality Assessments
• Contribute to preparation of the quality assessment plan through the identification of sub-optimal processes.
• Quality assessment execution: prepare agenda, interviews, opening, closing, reporting and CAPA follow-up.

Inspections:

• Contribute to inspection readiness activities
• Contribute to GCP inspections and ensure smooth organization of the front office and back office
• Provide responses and address questions and observations during inspection when observations are related to the role or responsibilities of the QA function
• Follow-up implementation of CAPAs and ensure timely completion

Audits:

• Support the audit activities by providing necessary study information to global audit group for risk assessment and audit plan
• Collaborate with R&D and GMA in the risk-based oversight of clinical service providers
• Assist in resolving compliance issues at clinical sites, clinical SP, laboratories and other SP by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation and ensure timely completeness
• Support global internal audits and implement CAPAs to address the issues raises

Quality Objectives:

• Develop and communicate Corporate Quality Objectives applicable to clinical research.
• Serve as liaison between the Global Quality System department and functional entities involved in clinical research.
• Share major deviations and serious breaches with the organization and ensure prevention across organization and alignment of CAPA

EHS Responsibility:

• Respect and ensure compliance with applicable EHS regulations and procedures.
• Promote an EHS dynamic within the teams for the proper functioning of the EHS management system.
• Participate in the prevention of accidents at work by carrying out Managerial Safety Visits (MVS) for its employees

Knowledge & Experience

Knowledge & Experience (essential):

• Minimum 5 years of relevant experience, including approximately 3 years of experience in a Quality position for Medical Affairs and/or Research & Development 
• Experience in interventional/non-interventional clinical studies
• Experience in Good Clinical Practices – Good Pharmacovigilance Practices – Good Pharmaco-Epidemiology Practices

Knowledge & Experience (preferred):

•  Analytical ability: Examines, recognizes and understands the essential elements of complex problems of which parts are partially unknown and is able to provide support with investigation methodology and definition of adequate CAPAs
• Ability to work within a dynamic, global team

Education / Certifications (essential):

• Bachelor’s degree in life sciences, Quality, or other related field

Education / Certifications (preferred):

•  Master’s degree or higher, preferably in Quality

Language(s) (essential):

• English

Language(s) (preferred):

• French

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The median hourly rate for this position is $48.15/hour

This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.