Materials Management Process Compliance Lead *PC 945

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

 Materials Management Process Compliance Lead 

Gaithersburg, MD

Your Tasks:

This role is responsible for driving process improvements across all Miltenyi Biotech shipping sites.  This role will do this by managing audit readiness, deviation investigations, CAPAs, and change controls within multiple North America warehouse sites associated with Miltenyi Biotech distribution and CDMO operations.  This role will take the lead in achieving and maintaining GMP, FDA, and ISO compliance.  The role will also be responsible for all stages in SOPs and business process management documentation.

Essential Duties and Responsibilities:

• Lead all deviation investigations, CAPAs, and Change Controls within the Materials Management department.  This includes working closely with Production, Operations, Materials Management, Quality, Quality Control, Procurement, and other Supply Chain functions across multiple levels.
• Own all warehouse and Materials Management SOPs from authoring, reviewing, editing, and implementing stages.  This will also require working independently across many functions to ensure we maintain a strong compliance culture.  This also includes working across sites to harmonize SOPs for common processes.
• Drive warehouse and Materials Management compliance with all GMP procedures and adherence to all GDP requirements.  This will require staying current on all regulatory changes for warehousing and Materials Management.
• Lead continuous improvement initiatives which will drive greater compliance, increase productivity, and customer satisfaction for warehouse and Materials Management function.
• Develop and maintain Work Instructions and Job Aids to assist in onboarding and continuous improvement training.
• Conduct internal compliance audits of processes and procedures.  This includes conduct investigation from quality and service complaints.  Generate audit reports and compliance KPIs for management.
• Develop, implement, and publish KPIs associated process quality in warehousing and Materials Management. 
• Take a lead role in supporting client and regulatory audits. 
• Responsibilities are across multiple businesses and sites for Materials Management.

Requirements:

• Bachelor’s degree (preferred) in Supply Chain, Inventory Management, Process Engineering, Communications or Business related fields OR Associate’s degree with extensive relevant work experience an Associate’s degree may be considered; a minimum of 8 years in production, operations, warehousing, quality, process documentation, regulatory compliance; a minimum of 8 years’ experience across warehouse operations, materials management, quality, compliance, process documentation, and other relevant Supply Chain roles; or a combination of education and experience. 
• A minimum of 3 years in a GMP or ISO environment.
• A minimum of 2 years in a supervisory or management role is preferred. Experience in procedure documentation and creation.  Six Sigma, LEAN, or other process certification.
• Microsoft Suite (Excel, Access, Power Point, Word). Quality Management Documentation Tools (Master Control or similar). ERP Systems (SAP Preferred).
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

Physical Demands:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms, talk, and hear.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a Shipping/Receiving/Warehouse Facility within an Office Building. Occasions in which this position must work outside, in which temperatures may vary. This position deals with temperature-controlled materials in which personal protective equipment (PPE) may be required due to extreme temperatures. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biotec North America, is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 Miltenyi Biotec, Inc. participates in E-Verify.