דרושים Sr Manager Commercial Development ב-West Pharma ב-צרפת

In this role you will be a member of the site leadership team and act as a true business partner and provide a full range of professional support and guidance covering recruitment, compensation & benefits, talent management, learning & development, health & safety, HR systems, labor relations and employee engagement. Act as an advisor to management and employees at all levels within the organization. Be the main point of contact for all French wide HR matters and responsibilities. Manage Le Nouvion, manufacturing plant and global functions part of French staff, growth and complexity, also regarding structure and cultural transformation.

• Leadership of the LN HR team and the French payroll team, i.e. 4 Business Partners, 1 Payroll Manager, indirectly 3 Payroll Specialists in Le Nouvion
• Support HR Director and the business as appropriate with the implementation of critical global, regional and/or local HR projects.
• Play a key role in the overall development of the site strategy as a member of the SLT ensuring that HR has input into key site decisions and operates as a true business partner. Provide strategic HR guidance to the LN plant manager, and deliver on key HR and site KPIs.
• Provide confidential counseling to senior leaders, customers, and colleagues on all HR matters.
• Plan and lead HR related change processes on plant level.
• Manage the recruitment and selection of employees at all levels of the organization. Promoting and positioning business as an employer of choice.
• Provide guidance and support to all departments and business units on resource requirements and employee relations issues.
• Support the identification and development of talent and succession planning across all levels of the business.
• Constructive cooperation with the local works council.
• Responsibility for negotiation of collective agreements with unions and works council.
• Responsibility for HR court cases and representation at court.
• Lead/support, as appropriate, the review and updating of all company HR policies, procedures and related documentation to ensure the business is compliant with the prevailing employment legislation in France, EU and also in line with West policies and procedures.
• Support department managers with organizational training by developing and managing training systems and processes for the organization (induction, up-skilling, technical training, development talent etc.). Maintain and drive continuous improvement of the HR software systems to include liaison with the relevant software suppliers and corporate IT.
• Guide managers in the effective performance management of their teams/employees, ensuring that issues are addressed in a timely manner.
• Guide line managers and employees with grievances and corrective actions. Provide input and support as required.
• Support the design, implementation and ongoing administration of key compensation & benefit arrangements.
• Build an employer brand in the market place.
• Responsible for the coordination and delivery of various HR/business initiatives, e.g. Our Voices, West without Borders, etc.
• Responsible for the weekly and monthly reporting of all key HR KPI data in support of the business.
• Ensure effective HR administration systems are in place and managed efficiently and complies to relevant legislation on data privacy and data retention.
• Manage the HR budget and support annual business budget process.
• In All HR and employee and labor matters, work in close partnership with HR central functions (L&D, TA) and Legal/Compliance.
• Other duties as assigned

• Bachelor's Degree in Business, HR or related field or equivalent experience required
• Master's Degree in Business, HR or related field preferred

• Minimum 10+ years of experience

• Experience in foreign companies with matrix organization
• Experience in managing complex projects
• Strong business knowledge and capability to assess HR implications of business priorities
• Strong knowledge in payroll and working time management
• Strong background in Labor Relations and French Labor Law
• Professional proficiency in English

• Human Resources\PHR or SHRM-CP preferred
• DDI certifications preferred

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• No min required 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

Responsible for providing quality leadership, governance, and expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance to regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Cultivate a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.
• Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations.
• Develop strong internal and external relationships with regulatory bodies and authorities.
• Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Responsible for developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis
• Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members.
• Responsible and accountable for quality departmental budget.
• Play a role as a key contributor to documentation updating, including leading any updates.
• Participate in and drive compliance to global harmonization initiatives.
• Responsible for quality data trending e.g., CAPA, Deviations, Customer Complaints, Product Quality KPI's and Change Requests and driving quality improvements.
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
• Acts as a mentor and coach to the business with respect to Quality and Regulatory knowledge.
• Fosters and encourages shared learning’s across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree Preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; required

• Minimum 10 years required and
• Previous leadership experience, preferably managing remote employees. preferred and
• Experience in regulated industry such as pharmaceutical and medical device. preferred and
• Project Management experience preferred

• Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other international regulations
• Familiarity with document management databases, particularly MasterControls and SAP.
• Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
• Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
• Excellent organizational skills with an ability to think proactively and prioritize work.
• Working knowledge of statistical data analysis
• Thorough understanding of validation activities and risk management principles and techniques
• Strong problem-solving and critical thinking skills
• Medical industry or highly regulated industry

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy