Simone Petersen Email & Phone Number

Copenhagen, Dk

Copenhagen, Capital Region, Dk

Bagsvaerd, Dk

Leading 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

Billingham, Gb

Member 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

Cambridge, Ma, Us

Member 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.

London, Gb

Led 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

London, Gb

Lead 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

London, Gb

Implement 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.

New York, New York, Us

Operational 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

New York, New York, Us

Chemical Safety Specialist for the site and the Dangerous Goods Safety Advisor. Reviewing materials from Transport requirements, storage, incident response and waste handling and shipment.

New York, New York, Us

Operational Safety Engineer for a large Production Facility, all site laboratories and the Engineering department.

New York, New York, Us

Education record

Bachelor'S Degree