Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 2K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Premium Employer

Sandoz

Compare

4.0

based on 401 Reviews

394 Sandoz Jobs

QA Team Head - (Genome Valley)

Sandoz

4.0

based on 401 Reviews

5-10 years

Hyderabad / Secunderabad

1 vacancy

QA Team Head - (Genome Valley)

Sandoz

posted 12d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Project Management Auditing Analytical Chemistry MS Office Risk Management

+ 2 more

Job Description

Lead the group, manage resources and capacities. Leading and managing a team with team leads and/or quality individuals at TRD GV sites QA function. Accountable for team objectives and deliverables as per objective setting. Supervise, guide and support global TRD project teams in all quality-relevant topics, questions, and issues. Develop project strategies in alignment with TRD considering all relevant cross-functional aspects to ensure the quality of deliverables within the project.

Job Description

Major accountabilities:

Lead and manage team, budget and resources according to objectives. Manage global TRD project team and represent TRD QA globally in TRD sub-teams, as well as at global quality board meetings and project development gate meetings.
Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
1. Experience in 3rd party management.
2.Experience in Manufacturing and analytical operations.
3. Data and digital technologies.
4. Advanced People Management skills.
5.Advanced Stakeholder Management and communication skills.
6.Agile and flexible
Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
Understand and proactively manage the interactions of project related activities between TRD QA and other departments inside or outside of TRD.
Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
Represent TRD QA in Due Diligence teams and provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate.
Provide input to contracts and QA agreements with 3rd parties. Approve project-specific QA agreement amendments for assigned projects.
Lead or participate in global and/or cross-functional initiatives.
Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.
Coach and mentor functional experts. Participate in recruiting process.

Minimum Requirements:

Education -

Masters (15 years pharma quality or operations) and 3-5 experience in people Management.
Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control.
Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs). Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments.
Experience in Technical Operations or equivalent experience from external company is preferred.
Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function.
Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes. Excellent organizational and project management as well digitalization skills. Ability to influence people, negotiate and communicate.