Simone Petersen Email and Phone Number
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Oversight of our Pharmaceutical Quality System at FDBD, External Audit& Inspection program, Deviation management of all Quality Deviations directly impacting and associated with Large Scale Manufacturing and Finished Goods and responsible for driving the advancement of our Learning and Training Program. Accomplished Leader in both proactive and reactive problem solving with over 25 years’ experience including Bio pharmaceutical, Pharmaceutical, Energy and Marine sectors; large-scale manufacturing, laboratory, R&D and commercial environments. Collaborative style with a demonstrated ability to communicate, negotiate and influence at all levels. Consistently delivering on goals and commitments, ensuring critical controls have the commensurate level of capacity to bolster the resiliency within an organisation to improve overall business performance. Ensuring that the people we work with are at the heart of everything we do.Extensive senior level experience in the design, implementation and leadership of Risk Mitigation strategies, policies and programs at local, multi-site, corporate, regional and global level; leading the adoption of common frameworks and standardised approaches across global organisations.Proven track record of building and leading successful cross-functional, multi-site and multi-business teams, maximising their potential and impact, in both start-up and change environments.Specialties: Pharmaceutical Quality Management Systems, Interacting with Corporate/Regulatory Agencies via Inspections and Audits, Quality Deviation Management, Strategy Development, Human and Operational Performance management.EHS Management Systems, ISO14001/OSHAS 18001, Safety Culture Assessment/Improvement, Behavioural Analysis, Occupational Health, Major Incident Investigation, Corporate Social Responsibility, Stakeholder Engagement, Start-up situations, change environments.
Bavarian Nordic
View- Website:
- bavarian-nordic.com
- Employees:
- 1569
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Global Ehs Director And Head Of Qa Ext. Manufacturing (Interim)Bavarian NordicCopenhagen, Dk -
Global Ehs DirectorBavarian Nordic May 2024 - PresentCopenhagen, Capital Region, Dk -
Head Of Corporate QaNovozymes Dec 2022 - PresentBagsvaerd, Dk -
Head Of Corporate Qa And Food SafetyNovonesis Feb 2023 - May 2024Leading two Corporate Quality functions Team 1: • Overall governance of the Corporate Quality Management System (QMS) for Novozymes. • Management of Regulatory Inspections, Certification Audits and Internal Audits including setting the Strategic direction for all business units to ensure accurate certification requirements per product are identified, achieved, maintained and built upon. • Oversight of all Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) management processes in addition to ensuring appropriate quality standards are maintained by all Contract Research Organizations (CROs) for execution of Clinical Studies. • Quality release of Investigational material/product for further development within Novozymes new ventures. • Quality oversight of Contract Manufacturing Operations (CMOs) and Suppliers • Global Management of all Kosher &Halal requirements and best practices• Governance of the Corporate Quality IT GxP IT compliance requirementsTeam 2 • Corporate Food Safety Management Program is focused on the ensuring the global coordination and alignment in food and feed safety for all business units in the Novozymes Corporation to enable an uninterrupted license to operate is maintained for current and future business ventures. • Setting the Global Requirements for hygiene and food/feed safety controls for manufacturing of Novozymes products • Raw Material Management including approval processes for both packaging and material • Subject Matter Experts on both Dietary Ingredients and Dietary Supplements -
Head Of Quality Continuous Improvement (Reg. Inspections, Pqs, Deviations, Learning, Change Mng)Fujifilm Diosynth Biotechnologies Aug 2019 - Dec 2022Billingham, GbMember of the site QLT, ESLT and Leading a department of three Quality functions with overall responsibility and oversight of · Pharmaceutical Quality System (PQS), Electronic Quality Systems (e-systems) & Regulatory Inspections· Operational Resilience/Quality Deviation Management working with Product Supply to investigate and resolve critical Non- Conformities assuring Product Quality to Market. · Learning and Development (L&D)and two Continuous Improvement specialists.Set the strategic direction and quality oversight of the site's PQS, QMR, MRB, Risk Management program and Electronic Quality Systems, L&D program, managed all critical quality deviations. Prioritization and management of QA Continuous Improvement Portfolio working across all aspects of the Product Supply Chain. Oversight of all Regulatory Inspections including FDA, EMA, DMA and Customer Audits. Integration of Biogen PQS to FDB and transformation of PQS to CDMO ready. Denmark representative for the harmonization of the Global FDB PQS Policies/DirectivesDelegated Global System owner for Electronic Quality System Change Management -
Head Of Regional Investigations, EuropeBiogen Oct 2017 - Jul 2019Cambridge, Ma, UsMember of Solothurn ESLT and Product Supply Leadership team. Lead and develop a multi-disciplinary team which has the responsibility for overseeing the facilitation and investigation of all Quality Deviations arising from Product Supply in Europe. Applying cutting edge analytical cause analysis techniques to each and every investigation, enabling an unparalleled confidence in identification of the cause(s) of the deviation. Identifying extent of condition and extent of cause and subsequent addressing of these through robust, risk based and sustainable CAPAs. Ensuring all facets of Human Performance principles where inherent in all steps of the deviation process as well as crucially the CAPA identification process. Constantly striving to identify process improvement initiatives and communicating learning from the both deviations and improvements across the organization. Building and maintaining stakeholder relationships ensuring open dialogue resulting in these tools, techniques and principles becoming the norm in the organization. -
North Europe Leader Ehs&S And Global Leader S&HLloyd'S Register Jun 2016 - Sep 2017London, GbLed team of HSES sub area Senior Managers for North Europe. Interim Quality Lead for Nordic and Baltic countries. Leading Sr Managers and the HSES team embedded within the business units (Marine, Energy and Quality Assurance) and specific countries to achieve area goals in a uniform and business effective approach while still enabling the individual businesses and cultures freedom to expand on corporate/group policies. Developed area's operational HSES approach & best practices in compliance with specific legislation of the sixteen Northern Europe countries where fixed offices are located including business policies utilizing corporate/group long-term strategy in co-ordination with area and global KPIs. Fostered positive reporting culture within the organization ensuring effective two way communication with all levels within the organizational structure and different business units. Engaged every level to enable colleagues to give feedback to highlight their concerns and areas of focus so that goals and objectives are realistic and meaningful to all. Identify areas for improvement in the LR Management System and coordinate continuous improvement projects using root analysis ensuring CAPAs and specific, measurable, attainable, realistic and timely (SMART). Tracking specific Projects with A3 plans.Promote Near Miss Safety Observations (NMSO) and open reporting culture. Lead investigations of significant near misses or work related incidents in cooperation with clients and facility operations. Utilizing root cause analysis techniques and Right First time principles.Responsible for the EHS budget planning and monitoring for North Europe including EHS training (internal and external costs), legislative compliance consultancy costs, PPE purchasing and all EHS associated contract negotiations and management.Interim Quality Lead for North Europe during the same period -
Head Of Environmental Health Safety & Security Nordic AreaLloyd'S Register Aug 2012 - Sep 2017London, GbLead a team of EHS professionals and set the operational EHS approach and best practices in compliance with Nordic and Baltic country specific legislation and business policies. 8 countries. Interim Quality lead for Nordic Countries. Review all incident data, investigate incidents through Root Cause Analysis and identify and evaluate CAPAs. Identify NMSO leading indicators and support programs to ensure improvement in these areas. Assist the regional safety teams in conducting investigations of significant LR Consulting NMSO. Evaluate the OHS& E performance based on the previous years KPIs.Identify Objectives and Targets for the forth coming year and facilitate the OHS& E management review for the Area.Complete Business Assurance Reviews (BARs) for LR and third party sites. Liase with Clients safety teams on moderate to high risk joint safety initiatives.Foster a positive EHS culture within the organisation and ensure effective two way communication with all levels within the organisational structure and the different business units. Identify areas for improvement in the EHSMS and coordinate continuous improvment projects using root analysis to ensure corrective actions are CAPAs and SMART. Coordinate the implementation of ISO14001 and ISO18001 in the Nordic and Baltic Countries along with recertifcation of these standards as appropriate. Successful extension to scope achievein both standards as of November 2014. Identify key both OHS Leaders and EMS representatives. . Support,co-ordinate and drive these teams OHS& E team members -
Global Health& Safety Leader, Lr ConsultingLloyd'S Register Jan 2014 - Sep 2016London, GbImplement the Lloyd’s Register Safety Management System within LR Consulting. Support the LR Consulting EMS program and ensure continuous improvement. Drive the LR Consulting related OHS programs and evaluate the effectiveness of these programs. Global LR C OHSAS18001 certication achieved as of June 2015. Review all incident data, investigate incidents through Root Cause Analysis and identify and evaluate CAPAs. Identify NMSO leading indicators and support programs to ensure improvement in these areas. Assist the regional safety teams in conducting investigations of significant LR Consulting NMSO. Support the Global Energy Management Team in successfully managing environmental, health and safety to promote an effective environmental, health and safety culture. Effectively communicate OSH&E information provided by LR Group or Region health, safety and environmental professionals in addition to communicating the specific LR Consulting and LR Energy business unit OSH&E topics. Assist in reviewing and communicating risk hazards for LR Consulting. Advice and mentor the Energy Service line Leadership Teams and all LR Energy personnel on OSH&E matters. Provide specialist support/advice within or across the Global LR Consulting energy business line. Ensure alignment of Global LR Consutling Safety goals with the other energy business units and LR Group Safety Objectives. Promote excellent OSH&E practices and sound environmental and safety behaviour across all Energy service lines, to comply with Group and Energy standards and legislation. Assist with the development and implementation of rules, standards and procedures on OSH&E. Identify external regulatory and client driven OSH&E initiatives that have a direct impact on the LR SMS and EMS. Monitor and review LR Consulting performance as well as performance within the Global Energy Service Lines. Identify areas for potential advancement and implement improvement projects and CAPA’s. -
Operational Safety Engineer And Dangerous Goods Safety AdvisorPfizer Jan 2009 - Jul 2012New York, New York, UsOperational Safety Engineer for large scale Pharmaceutical Production facility and Dangerous Goods Safety Advisor for the site. Some key responsibilities Mechanical Isolation, Electrical Isolation, Line Breaking and implementation of new programs/systems.Contractor and Project Management -
Chemical Safety SpecialistPfizer Jan 2006 - Jan 2009New York, New York, UsChemical Safety Specialist for the site and the Dangerous Goods Safety Advisor. Reviewing materials from Transport requirements, storage, incident response and waste handling and shipment. -
Safety Engineer Organic Synthesis Plant 1,2&3 Projects And EngineeringPfizer Jan 2002 - Jan 2006New York, New York, UsOperational Safety Engineer for a large Production Facility, all site laboratories and the Engineering department. -
Method Development Oh &Occupational Hygienist Qa DepartmentPfizer Jan 1996 - Jan 2002New York, New York, Us
Simone Petersen Skills
Simone Petersen Education Details
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University College Cork -
University College CorkBachelor'S Degree
Frequently Asked Questions about Simone Petersen
What company does Simone Petersen work for?
Simone Petersen works for Bavarian Nordic
What is Simone Petersen's role at the current company?
Simone Petersen's current role is Global EHS Director and Head of QA Ext. Manufacturing (interim).
What is Simone Petersen's email address?
Simone Petersen's email address is si****@****ail.com
What schools did Simone Petersen attend?
Simone Petersen attended University College Cork, University College Cork.
What are some of Simone Petersen's interests?
Simone Petersen has interest in Travelling, Spinning, Running, Cooking.
What skills is Simone Petersen known for?
Simone Petersen has skills like Process Safety, Hazard Analysis, Safety Audits, Risk Assessment, Corporate Compliance Auditing, Occupational Hygiene, Performance Metrics, Capa, Auditing, Industrial Hygiene, Pharmaceutical Industry, Quality Assurance.
Who are Simone Petersen's colleagues?
Simone Petersen's colleagues are Aleks Mamic, Monika Halle, Christopher Flokas, .adi Costescu, Sokar Rahman, Rasmus Johnsen, Sandra Mendoza Guerrero, Mph.
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