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GSK
Remote (Asia Time Zone Permitted)

Senior Manager, Quality Audit

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Senior Manager, Quality Audit

GSK
Salary : Login to view salary Apply from Source
Job Type : Full-Time
Education Requirement : Bachelor Degree
Skills :
Experience : 3 to 5 years
Work Days : Monday To Friday
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Job Detail

Site Name: Belgium-Wavre, Singapore - Field Based, USA - Pennsylvania - Marietta

Posted Date: Jan 15 2021

Are you energized by a highly technical quality assurance role that allows you to accelerate compliance and mitigate risk in a state-of-the-art manufacturing environment? If so, this Senior Manager, Quality Audit role could be an exciting opportunity to explore.

The primary responsibility of the Senior Manager, Quality Audit is to:

  • Ensure continuous GMP, Regulatory & Corporate compliance through audits of GMP processes for the GSK Vaccines sites, Global Functions and External Supply Sites
  • It encompasses functions and sites involved in the manufacture of sterile bulk antigens and aseptically formulated vaccines registered worldwide (i.e. North America, Europe & Asia).
  • Internal and external Vaccines supply chain for sterile bulk viral/bacterial/polysaccharide antigen processes, vaccine formulation, filling, packaging, distribution and manufacture of novel adjuvant.
  • Support continuous improvement of audit system and processes.

Key Responsibilities

Support and embed a ‘One Audit’ culture through audits and assessments at GSK Vaccines and Third Parties, i.e. Strategic Global Suppliers, Contractors, Licensees, Alliance Partners & future business partners.

  • Lead and participate in audit/assessment engagements as an independent reviewer of auditee procedures and processes. Activities include, but are not limited to team coordination, monitoring of progress towards plan, liaison with auditee, scope definition and overall assessment of internal controls for the applicable process(es) / risk(s).
  • Whether leading or participating on audits, provide leadership to ensure that audits deliver fit-for-purpose, risk-based assurance that is responsive to the current business and risk environment.
  • Collaborate across Internal & Third Parties commercial Audit Team and R&D audit team to ensure holistic consideration of risk and business context. Ensure that audits are delivered to the highest level of quality, and are conducted efficiently, maximizing team productivity.
  • Support the strategic Regulatory Inspection Management activities, i.e. assessments in preparation of strategic inspections, Health Authorities commitments verification.
  • Serve as a business partner to enhance GSK’s risk management capabilities and actively identify and share good practices and improvement opportunities.
  • Ensure transparent, balanced, open communication with business stakeholders to provide timely updates on audit progress and potential issues throughout the lifecycle of the audit.
  • Remain current with industry trends and changes in the regulatory and GXP standards. Participate to external forums and conferences to ensure external knowledge on GMP/GDP is brought in GSK.
  • Coach associates on the correct interpretation and implementation of regulatory requirements.
  • Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
  • Support development and continuous improvement of audit system and processes, including qualification of new auditors.
  • Sit in internal forums as the GMP/GDP expert providing recommendation for novel manufacturing an control processes or for new approaches in the GMP environment with the purpose of providing advice on how to ensure continued compliance to regulations while still supporting the simplification and advancement of the use of new technology.
  • Travel: 30-40%

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

  • University degree in Biology, Chemistry, Pharmacy or engineering, with experience in (bio)pharmaceutical manufacturing and quality operations.
  • 10 years of experience in a Pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC and Project Management roles.
  • Strong knowledge of regulatory and GMP regulations globally (Europe, North America & Asia)
  • Experience in computer system validation or specialized training in data integrity.
  • Experience in GMPs and international standards

Preferred Qualifications

If you have the following characteristics, it would be a plus:

  • Excellent English writing skills.
  • Global perspective; cultural sensitivity.
  • Qualified/Certified Auditor is a plus.
  • Self-motivated; Sense of urgency.
  • Strong problem solving and analytical skills.
  • Customer focused; ability to understand requirements of local sites.
  • Awareness of other GXP and exposure to Health Authorities is a plus
  • Ability to adapt, work under uncertainty and accommodate flexible work demands.
  • Verbal communications skills to ensure issues, risks and opportunities are well understood and that effective actions are put in place.
  • Good understanding of vaccines or similar biologics manufacturing and controls (primary and secondary operations) as well as raw material manufacturing technologies.
  • In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation).

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

  • Operating at pace and agile decision-making – using evidence and applying judgment to balance pace, rigour and risk.
  • Committed to delivering high-quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills, and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer, and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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