Strategic Program Director, Quality Liaison (Architecture)
About the Company:
Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.
Key Responsibilities:
Strategic Liaison
- Collaborate among Global Technical Operations (GTOps) Program Management, Operational Leaders and Global Regulatory Affairs to Develop, Implement and Execute Strategies for Merz Aesthetics Medical Devices that fulfill Operational and Commercial Business needs ensuring products meet quality standards and regulatory requirements throughout the lifecycle.
- Apply strategic thinking to guide the program plans and objectives across the business, geographies, and functions.
- Moderate and facilitate group discussions and strategic planning sessions for key internal and external stakeholders.
Leadership
- Provide guidance and leadership to project teams, engaging cross-functional SMEs as needed to execute and accelerate program timelines.
Process Improvement & Problem Resolution
- Proactively identify potential challenges and delays within the program portfolio and work cross-functionally to identify solutions and mitigations.
Metrics & Data
- Understand business environment and relate extensive knowledge of internal and external technological activities to trends.
- Utilize data from multiple sources to integrate effective business and regulatory intelligence into project portfolio.
Budget
- Work in accordance with approved budget targets and work cross functionally to effectively support GTO budget objectives.
Other Duties Assigned
Education
- Bachelor's Degree in life sciences, engineering, or related subject. Required
- Master's Degree. Preferred
Professional experience
- 10 years minimum in the Medical Products (Medical Device, Biotechnology, Pharmaceutical) industry. Required
- 7 years minimum in Global Medical Device Quality Assurance and/or Regulatory Affairs Role, including experience with Class II and III Devices. Required
- 5+ years in a strategic leadership role with strong project management skills. Required
Knowledge, skills, and abilities:
- Excellent written and oral communication skills with attention to detail. Required
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. Required
- Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission ready. Required
- Fluent in English, Additional Language Proficiencies are an asset. Required
- Thorough understanding and knowledge of applicable regulations and standards (ISO 13485, ISO 14971 and 21CFR Part 820 FDA regulations, MDSAP, EU MDR, etc. Required
- Expertise in design, qualification and control of clean facilities and critical utilities. Required
- Ability to work effectively in a global, matrix environment. Required
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required
Benefits:
• 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!
Your benefits and PTO start the date you're hired with no waiting period!
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 60-1.35(c)
Quality
