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8 Advanz Pharma Jobs
Associate Director - Quality Hypercare (Biosimilars QA)
Advanz Pharma
posted 12d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
About the Role
The Associate Director, Biosimilar Quality will provide strategic quality and scientific leadership on all aspects of biological products and the development and enhancement of the Pharmaceutical Quality System to ensure it meets Health Authority expectations.
The role will support the end-to-end oversight of a small portfolio of biosimilar products from the initial due diligence, in support of the Business Development and Licensing (BD&L) team, the review of the CMC modules of the dossier in support of the regulatory submission, launch preparations and Life Cycle Management.
The portfolio will consist of a range of products including in-licensed and development projects.
What You ll Do:
- The development of the Pharmaceutical Quality System to ensure it fit for purpose with respect to Biosimilar products
- Strategic Quality assessment of several new pipeline and M&A products in support of ADVANZ PHARMA s strategic initiatives and objectives.
- Support the Transformation Office and the Business Development and Licensing (BD&L) team, with the necessary Quality activities to ensure on time delivery of all pipeline projects.
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Proactively identify and highlight potential Quality risks, hurdles or issues which may impact project scope, and ensure practical resolution or escalation where necessary.
- Author/Review or Approve a comprehensive suite of SOPs to meet Health Authority expectations for the Quality Management of Biosimilars.
- Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others). Address issues/requests by the Agency during MAA.
- Participate in Audits of manufacturing and partner facilities.
- Execute Quality Review Meetings with our partners, escalating risks/issues appropriately to remove barriers to success or advise of delays and other changes which may impact Quality and or supply.
- Provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources.
- Act as subject matter expert in support of the Quality team in the review and approval of Quality System records, incidents and changes.
- Approve master batch records, procedures and protocols, Perform and oversee the lot disposition process.
- Perform change control assessments including document management, review and approve/reject change control, approve deviations and CAPAs and ensure all they are appropriately documented and investigated to determine and address root cause.
- Develop and implement annual quality plans.
- Ensure direct report(s) are actively and appropriately aligning with other teams to ensure timely and on-target results.
- Thrive in an entrepreneurial environment and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives.
For this role, you will also have the following:
Qualifications:
- Tertiary qualification in any discipline within Life sciences or
- Additionally professional qualifications.
Knowledge, Skills & Experience:
- Must be a subject matter expert in quality assurance of Biosimilars.
- Should possess strong experience in biopharmaceutical active substance production and analytics.
- Experience of working with Biologic and Biosimilar applications.
- Experience interacting with EU regulatory authorities Scientific advice meetings Open and adaptable to challenging environments.
- Broad knowledge and awareness of the European regulatory guidelines and legislation.
- Have a good understanding of early development and validation programs for Biosimilars.
- Excellent people management skills.
- Sense of urgency / willingness to operate within tight deadlines.
- Ability to work with colleagues across a broad range of disciplines and functions.
- Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others.
- A positive and can-do approach, biased towards finding solutions and embracing change.
- Inspired by our values of entrepreneurship, speed and integrity.
- Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows.
- Work collaboratively across all business functions with an open, honest, and respectful cooperation.
- Ability to have fun and thrive in a growing, unique, and inclusive work environment.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Advanz Pharma Benefits
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