Associate Director, Biomedicine Clinical Quality Assurance *PC 1485

Your Role:

The role will provide quality assurance and clinical compliance support to the MBM USA team for global GCP compliance, regulatory and MBM procedures compliance. The role will work in collaboration with the Miltenyi Global Quality Organization.

Essential Duties and Responsibilities:

Quality Compliance

• Support and ensure that all relevant legislation is fully addressed in Miltenyi Biomedicine policies, procedures, programs and training in MBM US
• Assist clinical team to address compliance questions and help to implement required guidelines and processes.
• Assure relevant GxP requirements and MBM internal procedures are followed.
• Assure cooperation and conformance with the global Miltenyi Quality Management System (QMS).
• Support the collection of metrics for monitoring compliance effectiveness.
• Support the embedding of a quality compliance culture into everyday Miltenyi Biomedicine processes in MBM Inc proportionate to the position and in alignment with wider Miltenyi Biomedicine global QA and operations.
• Develop and update procedures as applicable to meet the local regulatory requirements.
• Participate in project / program team meetings and relevant activities to provide compliance guidance as applicable.
• Advise operational teams on risks identification, mitigation and remediation actions.
• Support operational teams in vendor management from the quality standpoint.

SOPs / Quality Control of Documents

• Support the system for quality assurance of documents according to GxP and other regulatory requirements within Miltenyi Biomedicine US and in accordance with the global Miltenyi QMS.
• Support and organize development of SOPs.
• Support the update of SOPs and MBM procedures.
• Support the harmonization of the global processes.

Change Control

• Support the Change Control System.
• Support recording and monitoring of planned changes.
• Promote and support the effective use of Change Requests for impact assessment and implementation planning.
• Record and report on Change Control metrics.
• Support product release process.

Training Management

• Support the compliance-related training program for Miltenyi Biomedicine personnel in the US.
• Support the training development and delivery process for Miltenyi Biomedicine SOPs including implementation plans and the development of training materials for MBM Inc in the US.
• Support and ensure the maintenance of organization charts and GXP CVs which underpin regulatory/ client demonstration of the use of qualified personnel.
• Support the assignment of training modules to the curriculum.
• Support the maintenance of a training tracker for the recording of assigned trainings.
• Support the production of training completion reports and statistics.

Support audits and Inspections

• Support risk based annual audit plans.
• Support internal audits according to the annual internal audit plan where necessary.
• Support inspection readiness via training, audit response teams, mock inspections, and hosting audit/ inspection events in MBM Inc in the US.
• Develop study specific audit plans based on protocol profile and risks.
• Oversee outsourced audits for clinical sites and / or service providers. Ensure audit closure and follow up.
• Host, manage and follow up local regulatory inspections including supporting sites and liaising with service providers.

CAPA Management

• Ensure CAPAs are created resulting from audit / inspection reports or Complaints / Deviations as applicable
• Support root cause analysis and risk assessment with MBM QA and business lines and assist in assigning mitigation responsibilities for CAPAs.

Support Complaint and Deviation Management

• Ensure that complaints and deviations are performed according to the respective process
• Support recording and monitoring deviations / breaches and unplanned deviations
• Trend deviations and provide continuous improvement support to functions.

Support Vendor Qualification and MBM QA Supplier Management

• Ensure that all vendors and suppliers are qualified according to the global MBM QA procedures
• Ensure that the global MBM QA Manager is involved in all contracts and Quality Agreements.

Support Validation

• Support Computer System Validation (CSV) and other validations where necessary.
• May direct other QA resources, including contractors, including but limited to specialized audits (example: bioanalytical - GCLP,).

Requirements:

• Bachelor's Degree required (Masters preferred); Minimum 5 years of Clinical QA experience with relevant background in the pharmaceutical industry, including regulatory inspections; Or a combination of education and experience.
• Experience with GCLP conform handling of bioanalytical samples is advantageous.
• Highest levels of integrity and commitment to building Miltenyi Biomedicine reputation in the industry.
• Exemplary corporate citizen with technical expertise in ethics, quality and compliance.
• Proven experience of understanding a QMS and appreciation of Quality Risk Assessment.
• Understanding of Quality and Compliance Business Development activities.
• Excellent verbal, written and interpersonal communication skills.
• Analytical skills to manage trending and associated process improvements.
• Strong collaboration and negotiation skills.
• Work independent with little supervision required.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. 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.

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 variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

The anticipated base salary range has been established at $145,400- $196,700/year. The hiring range for this position is expected to fall between $145,400-$171,000, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity