Site Regulatory Compliance Head

Job Purpose

The Site Regulatory Compliance Head at GSK is responsible for ensuring that all company operations, products, and processes comply with relevant regulatory requirements. The role involves developing, implementing, and managing regulatory compliance programs and procedures to ensure adherence to laws, regulations, and guidelines set by regulatory bodies. The Regulatory Compliance Manager will play a critical role in maintaining the company's reputation and protecting it from GMP and regulatory compliance risks. The role ensures the risks are identified, escalated and mitigation plans In-place. This position ensures that all critical Quality Regulatory Compliance activities at the site comply with applicable regulatory authority guidelines, QMS requirements, cGMP standards, and applicable local standard operating procedures.

Education, Experience & Skills

• Science Graduate/Pharm D/ /Pharmacist
• Minimum 8 years of Experience in Quality Assurance, Regulatory Compliance, Quality Control, or a related field, including a position of significant leadership and decision-making authority within Quality or Regulatory functions.
• Strong knowledge of QMS, GMP and Regulatory requirements and guidelines

Key Responsibilities

• Manage Quality Regulatory Compliance and systems on site by creating and executing regulatory compliance strategies and programs.
• Ensure to monitor changes in global and local regulatory environment/regulatory requirements and ensure GSK processes and products comply with applicable laws and regulations.
• Establish, review, and update site procedures to align with regulatory requirements.
• Accountable for timely communication, correspondence with Regulators, government officials for warrantors, queries, cases and any other correspondence in liaison with Site, Legal and Regulatory team.
• Responsible for attending meetings and hearings with government officials and regulators in liaison with Site Quality Head
• Proactive engagement with regulator, where possible e.g. DTL, PQCB to expediate the current ongoing regulatory queries
• Investigate and resolve compliance issues, including conducting root cause analysis and implementing corrective actions.
• Identify Internal and external risks, where applicable develop risk mitigation plan and monitor the implementation plan.
• Governance of regulatory KPIs and processes and identify and assess compliance risks to develop effective mitigation strategies.
• Engage and communicate effectively with internal stakeholders and senior management to ensure alignment on compliance matters.
• Ensure compliance of the site-specific regulatory process for Management of Regulatory authority letters notifications and statutory regulatory orders (SROs).
• Ensure the Inspection readiness at Site, escalates any issues which impacting inspection readiness to site senior management.
• Represent the site during regulatory inspections in coordination with site relevant team.
• Develop and maintain accurate records of site product registration details, regulatory submissions and correspondence with regulatory agencies.
• Ensures compliance with QMS Implementation on site to comply with the requirements of the QMS, company internal policies, Global SOPs, and all related regulatory guidelines.
• Engages with the site to promote a culture of awareness and understanding of regulatory compliance.
• Provide training to employees on regulatory compliance topics to enhance their understanding and adherence to applicable regulations.
• Ensure to maintain accurate and up-to-date records of regulatory activities, decisions, and communications.
• Ensure reporting of compliance risks and issues to Site Quality Head, Site Director and at governance forum i.e. Site Quality Council, Site Leadership Team meetings.
• Permanent member of Site Quality Council and Risk Management Council Board meetings.
• This role may require traveling to attend regulatory meetings, conferences, visits or inspections.

Job Purpose

The Site Regulatory Compliance Head at GSK is responsible for ensuring that all company operations, products, and processes comply with relevant regulatory requirements. The role involves developing, implementing, and managing regulatory compliance programs and procedures to ensure adherence to laws, regulations, and guidelines set by regulatory bodies. The Regulatory Compliance Manager will play a critical role in maintaining the company's reputation and protecting it from GMP and regulatory compliance risks. The role ensures the risks are identified, escalated and mitigation plans In-place. This position ensures that all critical Quality Regulatory Compliance activities at the site comply with applicable regulatory authority guidelines, QMS requirements, cGMP standards, and applicable local standard operating procedures.

Education, Experience & Skills

• Science Graduate/Pharm D/ /Pharmacist

• Minimum 8 years of Experience in Quality Assurance, Regulatory Compliance, Quality Control, or a related field, including a position of significant leadership and decision-making authority within Quality or Regulatory functions.

• Strong knowledge of QMS, GMP and Regulatory requirements and guidelines

Key Responsibilities

• Manage Quality Regulatory Compliance and systems on site by creating and executing regulatory compliance strategies and programs.

• Ensure to monitor changes in global and local regulatory environment/regulatory requirements and ensure GSK processes and products comply with applicable laws and regulations.

• Establish, review, and update site procedures to align with regulatory requirements.

• Accountable for timely communication, correspondence with Regulators, government officials for warrantors, queries, cases and any other correspondence in liaison with Site, Legal and Regulatory team.

• Responsible for attending meetings and hearings with government officials and regulators in liaison with Site Quality Head

• Proactive engagement with regulator, where possible e.g. DTL, PQCB to expediate the current ongoing regulatory queries

• Investigate and resolve compliance issues, including conducting root cause analysis and implementing corrective actions.

• Identify Internal and external risks, where applicable develop risk mitigation plan and monitor the implementation plan.

• Governance of regulatory KPIs and processes and identify and assess compliance risks to develop effective mitigation strategies.

• Engage and communicate effectively with internal stakeholders and senior management to ensure alignment on compliance matters.

• Ensure compliance of the site-specific regulatory process for Management of Regulatory authority letters notifications and statutory regulatory orders (SROs).

• Ensure the Inspection readiness at Site, escalates any issues which impacting inspection readiness to site senior management.

• Represent the site during regulatory inspections in coordination with site relevant team.

• Develop and maintain accurate records of site product registration details, regulatory submissions and correspondence with regulatory agencies.

• Ensures compliance with QMS Implementation on site to comply with the requirements of the QMS, company internal policies, Global SOPs, and all related regulatory guidelines.

• Engages with the site to promote a culture of awareness and understanding of regulatory compliance.

• Provide training to employees on regulatory compliance topics to enhance their understanding and adherence to applicable regulations.

• Ensure to maintain accurate and up-to-date records of regulatory activities, decisions, and communications.

• Ensure reporting of compliance risks and issues to Site Quality Head, Site Director and at governance forum i.e. Site Quality Council, Site Leadership Team meetings.

• Permanent member of Site Quality Council and Risk Management Council Board meetings.

• This role may require traveling to attend regulatory meetings, conferences, visits or inspections.

Dlaczego GSK?
Łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby.

GSK to globalna firma biofarmaceutyczna, której celem jest łączenie nauki, technologii i talentów, aby razem pokonywać choroby. Jako odnosząca sukcesy, rozwijająca się firma, w której ludzie mogą realizować swój potencjał, dążymy do pozytywnego wpływu na zdrowie 2,5 miliarda ludzi do końca dekady.

Priorytetem są dla nas innowacyjne rozwiązania w obszarze szczepionek i leków specjalistycznych, które maksymalizują rosnące możliwości w zakresie zapobiegania chorobom i ich leczenia. 

Skupiamy się na czterech obszarach terapeutycznych: układzie oddechowym, immunologii; onkologii; HIV; oraz chorobach zakaźnych – aby wpływać na zdrowie na dużą skalę.

Ludzie i pacjenci na całym świecie polegają na lekach i szczepionkach, które produkujemy, dlatego zobowiązujemy się do tworzenia środowiska, w którym nasi pracownicy mogą się rozwijać i koncentrować na tym, co najważniejsze. Nasza kultura bycia ambitnym dla pacjentów, odpowiedzialnym za wpływ i postępowania właściwie jest fundamentem, na którym wspólnie dostarczamy rezultaty dla pacjentów, akcjonariuszy i naszych pracowników.

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Ważna informacja dla biur/agencji pośrednictwa pracy
GSK nie akceptuje poleceń pracowników od biur i/lub agencji pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie. Wszystkie biura/agencje pośrednictwa pracy są zobowiązane do skontaktowania się z działem handlowym i ogólnym/kadr GSK w celu uzyskania wcześniejszej pisemnej zgody przed poleceniem kandydatów firmie GSK. Uzyskanie uprzedniej pisemnej zgody jest nadrzędne w stosunku do jakiejkolwiek umowy (ustnej lub pisemnej) między biurem/agencją pośrednictwa pracy a GSK. W przypadku braku takowego pisemnego upoważnienia wszelkie działania podejmowane przez biuro/agencję pośrednictwa pracy będą uważane za wykonane bez zgody lub umownego porozumienia ze strony GSK. GSK nie ponosi zatem odpowiedzialności za jakiekolwiek opłaty wynikające z takich działań lub wynikające z polecenia danej osoby przez biura/agencje pośrednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie.