Role: Opella Global Safety & Medical QD & Training 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 patient 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 Safety & Medical QD & Training Manager Quality Manager is to manage the operational implementation of the Global QDs & Global Trainings systems within Pharmacovigilance, Medical, RWE & clinical organisation to ensure compliance to Global Quality standards and applicable regulatory requirements (GVP, GMP and GCP).
- Implement the QD strategy in PV, Clinical medical and RWE, according to the strategy defined by the QD & Training Lead, in collaboration with the respective Quality leaders.
- Work closely with / support SMEs to ensure timely authoring and approval of all QDs in a right first time approach
- With a continuous improvement mindset, review QDs and ensure Good Quality document practices are implemented.
- Coordinate QD process flow
- Perform Gap assessment and maintain Quality documentation
- Map and maintain QD packages using Connect master data as appropriate
- Manage CMS accesses
- Collaborate with Global QS&E team to secure timely completion of QD processes
- Build and maintain transversal QD related job aids applicable to Science Quality, with the input of DC Quality Managers and other roles involved in QD management in Science
- Maintain Science QD writing rules
- Build and maintain the dictionary of acronyms and definitions used in Science QDs
- Own the operating guideline related to QD management in Science
- Implement the Training strategy in PV, Clinical medical and RWE, according to the strategy defined by the QD & Training Lead, in collaboration with the respective Quality leaders
- Manage LMS accesses
- Maintain the Training Matrix
- Update and assigned local & global training curricula to global/local internal & external people
- Support managers in preparing on-boarding plans
- Escalate quality issue as appropriate to function quality leaders and direct manager
- Support Audit & inspection in PV, Clinical, Medical and RWE
- Ensure QD & training are fully compliant during inspection & audit preparedness
- Provide QD and training related documents and information during inspection & audit as per inspection lead instructions
- As the QD and Training Quality Business Partner for the Global Safety & Medical teams:
- Be the gatekeeper of the Global QD architecture
- Provide Quality input and guidance to QD authors
- Share regular QD & training overview to the Safety and Medical leaders
- Report QD & training KPI
- Secure CV & job descriptions storage
- As a member of the Science Quality Operations Team
- Optimize and standardize detailed operational quality processes for QD & training
- Closely interact with QD & training BPOs & BSO
- Back up to direct manager
- Report QD & training KPI
About you
- Experience: 5-10 years’ experience in QD & Training management
- Soft skills: outcome obsessed, change agent, decision maker, business partner, assertiveness, networking capability, collaborative & team worker, digital appetite
- Technical skills: QD & training management in regulated environment
- 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
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