Quality Control Manager Sto jobs at West Pharma in Germany

In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset.

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.

• Direct reports include quality control supervisors

• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.

• Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.

• Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.

• Identifies and develops opportunities to improve existing processes and procedures

• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.

• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.

• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.

• Exhibits regular, reliable, punctual and predictable attendance.

• Creates, prepares, implements and improves Quality Control KPIs metrics.

• Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.

• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.

• Ensures equipment is up to date on Preventive maintenance and calibration activities.

• Maintains the QC area well organized with a 5S mindset.

• Other duties as assigned

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

• Associate's Degree Associate's Degree in Technical or Engineering required or
• Bachelor's Degree Degree in Technical or Engineering preferred

• Minimum 8 years previous experience in Quality Control required and
• Experience in FDA regulated environment, pertinent to ISO 15378 preferred

• Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Metrology Equipment experience
• Leadership experience in leading teams preferred

• This job requires decision making based on data analysis
• Must be able to generate, express, and exchange new ideas
• Must be able to understand direction and adhere to established procedures
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & 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 multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problemsAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully execute supplier management plans which will align to overall business objectives
• Maintain a strong collaborative partnership with external suppliers and cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs

• Monitor supplier performance including incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
• Execute Supplier Corrective Action Requests (SCAR) with suppliers, ensuring effective and timely closure
• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance including supplier change request.
• Evaluate potential new or future suppliers and support supplier selection process with the cross-functional team
• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers during product development and ensures agreement for manufacturable, cost-effective designs
• Approves components for use in products by driving Product Approval activities with the suppliers
• Supports Supplier evaluation, audit management and related records
• Supports the evaluation and development of Quality Agreements and purchasing specifications with suppliers
• Support the development of an Incoming Inspection strategy on purchased products

• Bachelor's Degree in Science or equivalent experience required
• Master's Degree in Science or equivalent experience preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

• Leadership, development, and succession planning for the entire responsible area, especially the eight team leads.
• Personnel development and management, as well as overseeing higher-level personnel discussions.
• Management of the machinery park, including monitoring of inventory, throughput, and KPIs.
• Acting as a point of contact for the responsible area and serving as a liaison to upstream and downstream processes (compounding/finishing).
• Ensuring smooth production processes.
• Representing the department in audits, plant tours, and regular appointments or meetings.
• Leading projects in the areas of lean management, safety, major reconstruction measures, and the introduction of new technologies.
• Analyzing processes, developing, and overseeing optimization measures in the production area, as well as continuous process improvement.

• Successfully completed technical vocational training with further education to master craftsman or a similar educational level.

• Several years of professional and leadership experience in a production environment, preferably in the pharmaceutical sector.

• Very good knowledge of SAP and MS Office.
• Fluent German and good English skills in both spoken and written form.
• Successfully completed Lean and Six Sigma training (Green Belt) or a willingness to complete the training.
• Leadership competence as well as strong communication and presentation skills.
• Strong safety, quality, and responsibility awareness.
• Structured planning and independent target-oriented working style.
• High level of commitment and willingness to drive change.

• Program Activities:
• • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
  • Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
  • Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
  • Support design transfer activities for commercial and launch readiness and sustainment.
• Verification and Validation Activities:
  • Review and approve test method validations (protocols and reports).
  • Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
  • Facilitate and support the completion of projects up to and including PQ.
• Risk Management Activities:
  • Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
  • Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
• QMS Activities:
  • Support enterprise procedures updates that impact design and development activities.
  • Drive the closure of change controls and protocol non-conformance reports (PNRs).
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Act as the interface between development teams and operational quality:
  • Perform first article component and product inspections
  • Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
  • Support the supplier selection process in accordance with West supplier management procedures.
  • Conduct and support internal and supplier audits, as required.
  • Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
  • Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
  • Actively engage in robust problem-solving to address quality issues.
• Metrology Activities:
  • Review and approve metrology data during OQ & PQ.
  • Support Quality Function Deployment activities (QFD).
• Compliance to all enterprise and local company policies and procedures.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree in Chemistry, Engineering or Quality discipline required

• 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

• Desirable: Regulatory Affairs experience

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Must be able to organise and prioritise tasks.
• Must have critical reading skills, maintain a high attention to detail and overall quality of work.
• Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
• Strong problem-solving skills, including root cause failure analysis methods.
• Must have excellent written and verbal communication skills.

• ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to 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.

In this role, you will provide Quality Management System best practices across the programs you support. This role ensures regulatory and quality compliance and is responsible for planning, scheduling, executing and communicating all items regarding quality issues, complaints, validations and other projects in support of Customer Program Operations and product release. You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers. You take on responsibilities in customer and supplier communication and actively implement West's quality policy at the Stolberg site.

• Investigation and processing of customer and supplier complaints
• Leading departmental projects for lean work structures
• Supporting internal and cross-factory projects
• Initiating and following quality-relevant processes in local Deviation and CAPA Management
• Conducting customer and supplier audits and processing related reports
• Implementing measures from audit processes with internal and external stakeholders
• Supporting factory functions in root cause analysis and implementation of corrective actions
• Managing relevant change processes according to West Change Control Policy
• Assisting in local training within the framework of quality initiatives
• Assisting in the creation of summaries and statistics for management
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• Other duties as assigned

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of professional experience in quality or a quality-related interface
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required

• Proven knowledge in DIN ISO 9001:2015
• Very good MS Office and SAP skills
• Excellent German and English skills, both spoken and written
• Proficient use of statistical analysis tools (e.g., Minitab)
• Strong awareness of safety and organizational talent
• High teamwork capability and ability to act independently
• Strong problem-solving skills and project management experience
• Knowledge in DIN ISO 15378:2017 and Six Sigma Green Belt training are desirable

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.

• Management of incoming goods inspection within quality assurance, considering high security and quality standards
• Leadership and development of the incoming inspection team (7 people)
• Initiation, management, and support of optimization projects for raw materials and packaging materials in collaboration with suppliers and the global team
• Independent identification and resolution of quality issues
• Creation of deviations, out of specification (OOS) reports, and process changes, including trend analysis and initiation of improvement measures in the area of raw materials and packaging materials
• Central communication point for all internal and external departments regarding goods receipt inspection
• Data collection, evaluation, assessment, and trending of quality-relevant metrics for other departments
• Preparation of complaints and quality notifications in both English and German, and tracking their resolution
• Support of measures within the framework of out-of-specification (OOS) for raw materials and packaging materials, including preparation of necessary reports and documentation, assessment, and approval of CAPA measures in collaboration with the supplier
• Execution, documentation, evaluation, and follow-up on actions from internal quality audits
• Organization and execution of supplier audits

• Successfully completed studies in the natural sciences or engineering, preferably in chemistry or materials science

• Professional experience in quality management, preferably in the pharmaceutical sector or with GMP experience
• Leadership experience in managing teams of 5-10 people is preferred

• Solid knowledge of MS Office and statistical methods; knowledge of SAP is desirable
• Very good knowledge of German and English, both spoken and written
• Strong communication and teamwork skills
• Very good assertiveness and conflict resolution skills

• Member of the local site leadership team
• Provide HR leadership and direction for the site within your scope of responsibility.
• Supervise and provide guidance to direct reports.
• Develop organizational objectives and facilitate goals creation for broader functions.
• Work with senior management and other peers for strategy development and execution plan.
• Guide the talent identification and development processes.
• Oversee employee performance and communicate goals results.
• Use in-depth expertise and experience to provide HR support for various HR initiatives: performance and talent management, change management, workforce planning, leadership and employee development, onboarding and offboarding, compensation planning and benefits administration.
• Act as a trusted senior advisor to provide advice, clarification and follow-up on policies, procedures, benefits and compensation related items for employees, managers and global HR partners. Interpret and administer works agreements, HR policies, procedures, guidelines and programs, always ensuring alignment with global West in a consistent manner.
• Perform other duties as assigned based on business needs.

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

• Minimum 10 years of experience in Human Resources and role of HR generalist and/or HR manager required
• Deep experience and knowledge of multiple HR disciplines
• Good knowledge in German labor law and works council relationships
• Experience with HR business systems

• Passionate leadership.
• Proactive Change Management.
• Wide knowledge of employment law.
• Strong consultative, interpersonal and client orientation skills.
• Ability to work both independently and in a team environment.
• Capacity to handle confidential and sensitive information and issues in a discrete manner.
• Ability to work in a fast-paced environment in a global organization.
• Trustworthy, strong communication and presentation skills in German and English
• Decision making, planning and organizing, personal accountability and attention to detail.
• Ability to prioritize and respond timely to changing requirements and to coordinate multiple tasks simultaneously.
• Knowledge of MS Office applications.