Global Regulatory RWE And Medical 2RM Quality Operations Manager

Job Title: Global Regulatory, RWE & Medical (2RM) 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.

About The Job

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

The purpose of the Global Regulatory, RWE & Medical (2RM) Quality Operations Managers is to support the Global Regulatory, RWE and Medical teams and implement & maintain the Quality Systems to ensure that activities ares conducted and data are generated, documented (recorded), and reported in compliance with the GxP requirements.

Execute Global Quality Systems Operations for Global Regulatory, RWE & Medical (2RM) 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

Quality document & training

• until Regulatory and Medical TSA exit – under the Global QD & Training head guidance – implement QD & Training management in 2RM
• perform Gap assessment and maintain Quality documentation
• Map and maintain 2RM QD packages
• Update and assigned local & global training curricula to global/local internal & external people
• Support managers in preparing on-boarding plans
• Manage CMS & LMS access
• Report QD & training KPI
  
  

As the Quality Business Partner for the Global Regulatory, RWE and Medical teams:

Provides Quality System expertise and support to Global Regulatory, RWE and Medical teams in the execution of Quality Systems

Support Connect access management for Global Regulatory, RWE and Medical 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 Regulatory, RWE and Medical leadto ensure timely execution and full compliance in alignment with Quality strategy

About You

Experience: solid experience in Quality systems (5-10 years)

• Soft skills: client orientation, outcome obsessed, looking for simplification, assertiveness, networking capability, collaborative & team worker
• Technical skills: quality systems– Regulatory, RWE and Medical
• 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 others 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

---