Director of Global Quality Sterility Assurance - Merz North America, Inc

This role is based on-site in Sturtevant, Wisconsin with routine travel to Merz Aesthetics Global Manufacturing and Contract Manufacturing sites.

Key Responsibilities

Sterility Assurance Program Alignment & Strategy

• Establish global sterility assurance and contamination control governance programs (policies, standards and procedures, validation strategy design).
• Drive harmonization/optimization of multi-site microbiological processes (e.g., sterilization, cleanroom design and qualification, effective bioburden/microbial control strategies/risk assessments, critical utilities, environmental monitoring program, microbiological testing programs for raw materials, intermediate products, and finished products as applicable) for Merz products, produced at Merz manufacturing facilities and at affiliated contract manufacturing facilities globally.
• Provide global oversight regarding validation of microbiological laboratory methods including bioburden, endotoxin and sterility assays as well as microbial identifications used to support Merz in-process, release and stability testing programs internally and externally (CTOs/CMOs).

Leadership

• Representation of Merz technical position through external engagement and leadership during regulatory and third party inspections.
• Development of highly competent technical staff and future sterility assurance technical leadership
• Engagement with senior/executive leadership including knowledge transfer and strategic guidance.

Process Improvement & Problem Resolution

• Establish proactive surveillance of global and emerging regulatory requirements
• Lead implementation of automation and adoption of novel technologies
• Lead complex investigations about microbiological deviations in manufacturing and/or in laboratory; monitor laboratory out of trend (OOT) and out of specification (OOS) investigations
• Support Product and Process Risk Management processes
• Provide technical and compliance support, in the context of microbiological processes: for site and product-related inspections (e.g., Pre-Market Approval (PMA) Inspection and periodic cGMP inspections; to manufacturing and quality during manufacturing and/or laboratory deviation investigations, change control and CAPAs; for escalations, regulatory notifications and market actions.

Metrics & Data

• Establish a global system for routine review of sterility assurance system data, including internal/external audit execution and results to determine compliance gaps and associated mitigation plans on a global level
• Define, implement and improve tracking mechanism for compliance progress

Budget

• Manage Departmental Budgets in accordance with approved targets, work cross functionally to effectively support GTO budget objectives

This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time. 

This job description may be altered at any time during the course of employment with functions added, deleted and/or altered as necessary.

Education 

• Bachelor's Degree in Microbiology or related physical science Required
• Master’s degree in Microbiology or related physical science or Business Preferred

Professional Experience

• 10 years minimum in the Medical Products (Medical Device, Biotechnology, Pharmaceutical) industry Required
• 7 years minimum in a role in a cGMP organization with a focus in Microbiology and Sterile Product Manufacturing

Skills/Competencies

Knowledge, skills and abilities (incl. languages)

• 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 (required), Additional Language Proficiencies are an asset
• Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority.
• Expertise in design, qualification and control of clean facilities and critical utilities.

Knowledge of methods

• Thorough understanding and knowledge of applicable regulations (ISO 13485, ISO 14971 and 21CFR Part 820 FDA regulations, MDSAP, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc.) – required
• Experience in data analysis and statistical evaluation and trending of microbiological data.
• Experience in sterility assurance validation (terminal, aseptic, and/or reprocessing) and environmental controls for pharmaceutical manufacturing facilities.
• Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
• Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferred).
• Expertise in investigations/deviation management including, writing and evaluating microbiological OOSs and laboratory investigations and manufacturing investigations.

Personal skills

• Ability to work effectively in a global, matrix environment required
• Ability to work independently as well as direct and control the efforts of Direct Reports 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