Research and Development Quality Manager

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

R&D Quality Manager of is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to New Product Development, Introduction & Launches (NPD, NPI & NPL), GCP Quality Assurance and associated Technology Transfers from R&D or Customers to commercial settings. This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and internally established standards and practices

MAJOR DUTIES AND RESPONSIBILITIES:

Manage and oversee R&D Quality Assurance activities which include, but are not limited to:

Reporting to the CQO, the R&D Quality Manager will be a core member of the QC & QA team and responsible for the oversight of the QMS and the implementation, management, ongoing support, and review of FS’s internal GXP validated systems.

This individual will ensure Quality and Risk Management standards are defined, understood, designed into work activity, and achieved.

This role will ensure compliance risks are identified, mitigated, and managed appropriately.

Establish appropriate activities supporting the management and oversight of quality for applicable processes.

New Product Development, Introduction & Launches (NPD, NPI & NPL), GCP Quality Assurance and associated Technology Transfers, Technical Risk Assessments (TRA), Process Control Strategies etc., raw material and components onboarding, from R&D or Customers to commercial settings.

Provide Quality Oversight for Analytical Method Development and Validation as well as Process Validation.

Oversight of key QA systems such as investigations, Significant Quality Events (SQEs)/deviations, CAPAs, audits, developing and managing integrated Quality Management Risk plans

Promote continuous improvement by partnering with key stakeholders to identify trends in quality events and ensure risk-based solutions are implemented in a timely manner and escalated to senior leadership.

Define metrics and measures for R&D Quality to drive assessment and continuous improvement

Oversee NPD, NPI, NPL stage-gate Process, GCP Quality investigations in collaboration with cross functional department owners

Participate and represent R&D Quality in meetings and discussions as needed

Participate in the metrics review as part of the Quality Management Risk approach to identify gaps, trends, and the need for process improvements

Support the inspection readiness activities and participate in managing regulatory health authority inspections as needed

Oversee Quality activities related to FDA and ROW regulations and Customers across therapeutic areas and provide NPD, NPI, NPL and GCP guidance for all phases of drug development

Support routine and for cause audits of investigative sites and vendors and support internal audits

Develop, review, and approve Quality - documents (e.g., SOPs).

Identify and escalate potential serious GCP non-compliances within R&D Quality management and relevant cross functional management

Implement existing Quality Strategy and divisional and department-specific guidelines in all areas for which the job holder is responsible.

Partner with Business Owners on continuous improvement of data management practices and documentation relating to the application of ALCOA+ principles of GXP data integrity throughout the data lifecycle, including data mapping and criticality assessments.

QUALIFICATIONS:

Bachelor of Science degree (Chemistry, Biology, Physics, Biomedical Sciences, Pharmacy, Industrial Pharmaceutics, etc., Master’s or PhD advantage Expert knowledge of NPD, NPI, NPL, GCPs particularly ICH requirements

Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors

Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.

Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance

Proven ability in setting strategy for and driving quality process improvement initiatives

Strong leadership experience and mentoring skills

Strong global knowledge and understanding of international regulations applicable to the conduct of new product development, introduction and launches, clinical trials and pharmacovigilance operations

Strong leadership, coaching and mentoring experience, influencing, leading direct and/or indirect reports.

Other duties as assigned

Demonstrated ability to manage multiple and diverse projects concurrently.

Demonstrated ability to develop positive relationships and collaborations.

Strong analytical skills; a strategic thinker, planner, and implementer.

Reliable, dependable, and consistent worker.

Strong ability to create practical and efficient processes.

Highly effective interpersonal skills in individual as well as in group settings.

Strong communication skills, both written and verbal.

Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Results-oriented; able to determine approaches to assignments.

Problem-solving skills with the ability to analyze situations and/or data while considering future impact and intangible variables.

Demonstrated attention to detail, accuracy, excellent review, and analytical skills in a fast-paced environment.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Must have strong oral and written communication skills and SOP-development experience.

Ability to work independently under general direction in a fast-paced environment.

Ability to travel up to 10% (domestic and international).

CRITICAL SKILLS AND ABILITIES:

Ability to use a personal computer and measuring devices.

Attentive to detail, thorough and accurate.

Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

Ability to perform effectively under conditions of fluctuating workload.

Ability to handle and resolve recurring problems.

Communicate with others clearly and concisely.

Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.