Job Title: QA Senior Manager
Location: India - Hyderabad
Work Location Type: On-Site
Date Posted: Feb. 04, 2025
Category: Quality
Job Summary:
Join Amgen’s mission to change the world! As a QA Senior Manager, you will play a critical role in ensuring all Quality Requirements are met, managing GMP inspections, and supporting inspection readiness activities. You’ll oversee Design History Files (DHF), contribute to design and development strategies, and collaborate cross-functionally to drive excellence in Combination Product Operations.
Key Responsibilities:
Provide Quality technical expertise, oversight, and serve as a single point of contact for Combination Product Operations activities.
Attend development program meetings as part of program working teams.
Guide documentation structures, ensuring GMP or Non-GMP phase-appropriate strategies and repositories for compliance.
Act as QA contact for change controls and review relevant Design Control documentation.
Create and maintain Design History File Index, Device Design Traceability Matrix, Quality Combination Product Plan, and EDO Control Plan.
Provide Quality oversight of Design Characterization, Verification, and Validation activities.
Contribute to regulatory submissions and respond to RTQs; support audits and inspections.
Ensure program alignment within Design and Development Plans, Risk Management Documentation, and EDO Control Plans.
Provide oversight for Human Factors Engineering (HFE) protocols and reports.
Participate in deviation, CAPA, and complaint investigations for commercial programs.
Support internal/external audits and inspections with preparedness and formal responses.
Act as an independent reviewer for combination product program design reviews.
Collaborate with CPO for management review topics and provide quality advice on regulatory strategies.
Manage program budgets and evidence-based resource planning.
Lead and develop highly qualified staff, ensuring operational excellence.
Basic Qualifications:
Doctorate degree and 2 years of quality and/or design space experience OR
Master’s degree and 8 to 10 years of quality and/or design space experience OR
Bachelor’s degree and 10 to 14 years of quality and/or design space experience OR
Diploma and 14 to 18 years of quality and/or design space experience
Preferred Qualifications:
Quality and manufacturing experience in biotech or pharmaceutical industries.
Expertise in NPI/NPD (New Product Introduction/Development).
Strong leadership skills with the ability to manage multiple complex projects.
Familiarity with GMP, GDP, and pharmaceutical regulations.
Experience in audit cycles and interfacing with regulators.
Knowledge of quality engineering, mechanical engineering, and applicable standards (e.g., MDR, ISO 14971, ICH Q9/Q8/Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210, 211).
Prior experience with combination product launch teams.
Effective negotiation, workload management, and decision-making skills.
Ability to travel up to 20% domestically and internationally.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Argentina | Peru |Brazil :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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