External Quality Manager

6 days ago

Mumbai, Maharashtra, India Ortolan Full time

External Quality Manager

Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed and detail-oriented pharmaceutical Quality Manager, with experience in managing the Quality aspects of contract manufacturing organisations, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

We act decisively but we never compromise on quality.We keep our promises and do as we say.We value our heritage and foster an entrepreneurial spirit.We reinvest in our future - in our products, our brands and our people.We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As External Quality Manager, you will play a key role in overseeing the Quality aspects of external manufacturing operations including Quality Agreements, audits, deviation management, and product lifecycle support - ensuring compliance and collaboration across Pharmanovia's global supply partners.

Our ideal candidate will have experience within the pharmaceutical industry handling third party manufacturing organisations with a number of following disciplines: Quality Systems, Quality Operations, QC Laboratory, Analytical or Process Validation, Manufacturing, Production or Warehouse.

The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities & duties:

Write, review and negotiation of Quality Agreements and to ensure key responsibilities are documentedCompletion of assigned Quality Technical Agreements in line with project timelinesProvide effective quality oversight of the Quality aspects of several contract manufacturing organisations during project phase and transition to business-as-usualSupport planning and execution of audits of third partiesQuality oversight CMO Deviations, Change Controls, complaintsSupport timely discussion of OOS results with other Quality/Technical staffQuality support for qualification of a new CMOLeading reviews investigations in a timely manner and timely escalations to the manager/QP as requiredLiaise with internal and external stakeholders as required to achieve timely completion of all CAPAs relating to customer & internal audit CAPAsEnsure oversight of the product stability set up activities for productsTimely completion of ad hoc and other tasks as assignedQuality support for product technology transferTo identify, review and present any quality risk associated with product and escalate to project manager and line manager.Building the relationship with affiliate companies and CMOs for the designated products from Quality point of view

About you:

Candidates with progressive experience in managing CMOs across several disciplines within the pharma environment should have the skills and experience required for the role. We are also looking for:

Bachelor's degree in pharmaceutical sciences or equivalent, postgraduate degree or diploma is a bonusLead Auditor Qualification (and additional Supplier Qualification is a plus)Excellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, TeamsQuality software skills (Trackwise, SAP) desirableGood working knowledge of current GMP, SOPs, EU GMDP guidelines and regulations and ICH guidelinesStrong QMS elements knowledge and experience (Deviations, OOS, Investigations, CAPA, change management, complaints)Experience of manufacturing solid dosage forms, liquids, creams and sterile productsExperience of routinely preparing and negotiating Quality Technical AgreementsExperience of facilitating OOS and Root Cause AnalysisKnowledge of GDP is desirableExperience of Technology Transfer and Nitrosamine risk assessment is desirablePrecise and attentive to minute details while reviewing critical due-diligence documents to escalate the manager on product quality issueAbility to work on own as well as part of team, collaboration across cross-functional environmentsAbility to build strong professional relationshipsExcellent professional English communication skills, both written and verbal

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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