- New Technologies: Evaluate and Implement New Technologies for Merz Technical Operations (Manufacturing Execution System (MES), Enterprise Resource Planning (ERP), Electronic QMS (eQMS), Laboratory Information Management Systems (LIMs) etc.). in collaboration with global, cross-functional team. Secure firm knowledge transfer of project drivers, business processes, and business requirements to delivery teams at project initiation and support on-going system use and training of users in accordance with cGMP Expectations to Improve Compliance, Quality Levels (reducing defects), and Improve Operational Efficiencies.
- Global Alignment & Strategy: Guide the business technology investment strategy to ensure it is aligned with Global Technical Operations priorities and embedded across the business.Lead, influence, and evolve the operating model to maximize business outcomes and identify opportunities for delivering innovative technical and digital capabilities commensurate with the needs and requirements of a Global Medical Device and Pharmaceutical company. Partner with internal and external stakeholders in the design, engineering, validation and implementation of data, software, or technology solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas; Routinely demonstrate initiative and creativity in developing technology solutions.
- Operational Technology and Cyber Security: Collaborate with Global Colleagues to establish and fulfill Operational Security Plan, Coordinate management of security incidents and vulnerabilities, Collaborate with IT Security, and Information Security Departments to improve security, Secure OT computing network.
- Inspections and Audits: QMS Subject Matter Expert for regulatory inspections and audits.
- Personnel Management: Allocate human resources and deploy appropriate methodologies to fulfill near term goals and commitments while ensuring Sustainable Performance. Motivate and lead team to Achieve Business Objectives.
- Budget: Manage Departmental and Project Budgets in accordance with approved targets.
- ISO27001 Knowledge and/or equivalent practical experience.
- IT/OT Security Focus.
- Demonstrated strong project management skills including ability to prioritize tasks and adhere to agreed timelines.
- Must be able to directly lead and/or co-lead high-impact process improvement projects.
- Strong technical and general problem-solving skills required.
- Ability to manage priorities in a fast-paced environment.
- Proven skills working with cross-functional teams.
- The ability to drive change and foster an environment of continuous improvement.
- Ability to work with company staff and communicate effectively throughout the organization.
- Excellent written and oral communication skills with attention to detail.
- Strong analytical/statistical problem-solving skills.
- Knowledge and familiarity with cGMP, cGLP, etc. for Medical Device / pharmaceutical organizations.
- Ability to work effectively in a global, matrix environment.
- Ability to work independently as well as direct and control the efforts of Direct Reports, as applicable.
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts.
- Minimum 8 years related experience, with at least 5 years in the Medical Device / Pharmaceutical Industry. - Required
- Bachelor's degree or equivalent experience. - Required
- Master's Degree in a related field. - Preferred
- Certified cyber security professional accreditation preferred (such as CompTIA Security+ certification). - Preferred
- Comprehensive Medical, Dental, and Vision plans.
- 20 days of Paid Time Off.
- 15 paid holidays.
- Paid Sick Leave.
- Paid Parental Leave.
- 401(k).
- Employee bonuses.
- And more
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Sr. Manager, Business and Operational Technology - Racine, United States - Merz North America
Description
About the Company:Family owned since 1908 Merz Aesthetics is the world's largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.
As Sr. Manager, Business and Operational Technology, you will partner with Global Technical Operations and Global IT on the Tech Ops Technology strategy for Merz Aesthetics. You will partner with Global Colleagues to assure Global Quality Systems Objectives are Identified and Fulfilled, Drive Continuous Improvement and Motivate and Lead your Team to Achieve Business Objectives.
Key Responsibilities
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
