3 Group Leader jobs in Ireland

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Group Leader - Biopharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our steam with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The role is to provide support to our Biopharma department by providing management and direction to a group of laboratory staff and resources for project activities and needs, coordinating daily operations to supervise quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs.
**A day in the Life**
+ Management of a team of supervisors and analysts
+ Allocation, scheduling and leading laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
+ Reviews and approves study protocols, project status reports, final study reports and other project related technical documents.
+ Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.
+ Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.
+ Prepares and approves proposals, project definition and pricing. Participates in negotiations with client on timelines and budget.
+ Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions.
+ Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.
+ Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.
+ Participates in bi-annual SOP review and change. Ownership of changes needed to follow SOPs.
+ Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.
**Education and Experience**
Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, & experience.
+ 2+ year of management responsibility
**Knowledge, Skills, Abilities**
+ Confirmed leadership skills and ability to cultivate a collaborative work environment with a team
+ Management experience in the pharmaceutical, biotech or analytical contract laboratory industries
+ Stability/QC/analytical R&D/project and program management.
+ Direct supervision of technical staff.
+ Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements, EMA and FDA guidance's.
+ Knowledge and experience of a wide range of techniques, HPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.
**Management Role:**
Leads experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Lifecycle Safety Project Management team** manages the delivery of lifecycle safety from trial initiation to closeout. Ensures quality deliverables are presented on time and within budget; coordinates work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.
As an **Associate Director, Safety Project Leadership and Strategic Solutions** , you will provide strategic leadership at customer account level for multiple large projects, as assigned by senior management team. Act as Sponsor's primary point of contact throughout project duration for local and globally scoped deliverables (programs) with single/multiple Lifecycle Safety functions. Collaborate with global management team to develop and implement strategic initiatives and ensure global consistency.
**Main Responsibilities**
+ Manage the delivery of lifecycle safety from trial initiation to closeout, ensuring quality deliverables are presented on time and within budget.
+ Coordinate work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies.
+ Identify and evaluate potential project risks and develop mitigation plans.
+ Serve as the primary point of contact with the project sponsor.
+ Collaborate with the global management team to develop and implement strategic initiatives and ensure global consistency.
+ Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities and drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence, and excellent customer communication.
+ Manage scope and budget review and finalization with sponsors, ensuring program financial targets are met.
+ Accountable for oversight of Lifecycle Safety performance for projects/programs on assigned accounts, including customer interface and communications, customer deliverables, realization/profitability, service integration, and technical solutions.
+ Prepare, present, and respond in bid defense meetings and discussions, and input into more complex requests for information (RFIs) or requests for proposal (RFPs).
+ Liaise with Business Development to provide timely inputs regarding the feasibility of new proposals going out to clients.
+ Contribute at IQVIA internal cross-functional project team meetings, interfacing with other functional leads, customer project status meetings, and oversight group meetings.
**Minimum Required Education and Experience**
- Bachelor's Degree Health science or other directly related field.
- 8 years' Clinical Research experience in a Contract Research Organization or Pharmaceutical company combining 5 years of Lifecycle Safety experience (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) or equivalent combination of education, training or experience.
- In depth knowledge and understanding of Lifecycle Safety service lines.
**Skills and Abilities**
- Strong business acumen; financial management and budgeting skills.
- Strong project management; strategic planning; delegation and organisational skills.
- Proven ability to work on multiple projects and manage competing priorities.
- Strong leadership, motivational and influencing skills.
- Strong customer focus.
- Demonstrates financial awareness. Promotes good practices to manage financial performance.
- Excellent communication, presentation and negotiation skills.
- Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level.
- Autonomous independent decision-making; problem solving and judgment skills.
- Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities.
- Strong ownership skills: take initiative and move forward with limited guidance. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations.
**This role is not available for a UK visa sponsorship.**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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