Job Title: Global Clinical Quality Operations Manager
Location: Hyderabad
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at
www.opella.com
.
Our Team:
Opella Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patients safety.
Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements.
Main responsibilities of the mission:
The purpose of the Global Clinical Quality Operations Managers is to support the Global Clinical team and implement & maintain the Quality Systems to ensure that clinical trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP and GMP requirements.
Execute Global Quality Systems Operations for Clinical regulated activities
- Event & CAPA :
- perform QA assessment, check root cause analysis, investigation report
- review CAPA and approve closure
- secure timely closure of investigations and CAPAs
- escalate risk as required to 2RM Lead and to manager
- Change control :
- Create Change Control as per 2RM Quality Lead assessment
- coordinate until Change Control closure
- secure timely closure
- Audit & inspection operations
- run risk tool
- contribute to Global/Local audit & inspection preparedness
- monitor and support CAPA closure
- Vendors quality management: perform qualification (questionnaire, QTA…) and maintain the list of preferred vendors (G2 market excluded)
- Performance management : report KPI and escalate issues with remediation plan
- Product Complaint : as the Complaint officer, manage Clinical Product complaint
As the Quality Business Partner for the Global Clinical team :- Provides Quality System expertise and support to Clinical Study teams and Clinical Supplies team in the execution of Quality Processes
- Support CONNECT access management for Global clinical teams
- Manage access review
- Support manager in access management
- Elevate Quality Culture
As a member of the Science Quality Operations team in Hyderabad
- Collaborate with other Science Quality Operations managers to standardize and continuously improve operational processes
- Closely interact with Quality System team and BPOs
- Back up other Quality Operations managers
- Maintain Quality processes Job aids package
As a member of Global Science Quality
- Report relevant information to prevent or revert quality crisis to Quality lead and direct manager
- Manages special projects assigned by supervisor as relevant
- Participate to the Quality meetings as a Science Quality representative
- Collaborate closely with the Global Safety and Clinical lead to ensure timely execution and full compliance in alignment with Quality strategy
About you
Experience: solid experience in Quality systems (GMP and/or GCP) and/or clinical supplies operations & clinical trials management (5-10 years)
- Soft skills: client orientation, outcome obsessed, looking for simplification, assertiveness, networking capability, collaborative & team worker
- Technical skills: quality systems (GMP annex 13 and GCP) – Clinical Operations & clinical supplies
- Education: Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields)
- Languages: English is compulsory (working language) - other languages welcomed
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
Report job