Director Regulatory Compliance
PURPOSE OF THE POSITION: This position is responsible for working closely with the VP of Regulatory Compliance and Pharmatech’s sphere leadership to build and execute the strategic plan for the Compliance group.
This position requires expert knowledge in the design, deployment, maintenance and management of modern Quality Systems as they relate to the pharmaceutical, biotech and medical device industries. The candidate must have an exceptional understanding of the US FDA regulatory compliance requirements as well as ICH Q-X best practices documents and expectations. This candidate must also have a strong practical working knowledge of the European compliance expectations as defined by EMA and Eudralex documents.
This position will be responsible for designing and executing sophisticated and complex projects in the regulated life science industry. These projects may include elements from all of the following areas; Regulatory Filings, QMS Design, QMS Assessment (audits) and Remediation, pharmaceutical/biological product and process development, technology transfer/scale up (local and international) and the Design and Development of Medical Devices (drug delivery systems (combo products), diagnostic systems (from Dx kits to gene sequencing systems). This position will lead teams of multi-specialized SME’s consisting of both employees and Independent Contractors engaged to complete all aspects of the defined project. This position, while working with the Project Manager, will have key customer interface requirements to; create the project design, gain customer acceptance of the project, keep customers technically informed as the project is in execution and create and deliver all final reporting documents required to successfully close the project.
MAJOR RESPONSIBILITIES: Within this context, the Compliance Director will be responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy,commitments and goals.
- The Compliance Director will be responsible for procuring and supporting potential new client sales as a technical expert within the organization for the following:
- Identify and engage potential new clients that will grow the Compliance organization commensurate with identified growth targets established on an annual basis
- Develop project proposals including staff and cost breakdown
- Work with clients to complete successfully the project approval process
- Identify and secure appropriate project resources
- Manage projects scope and deliverables
- Develops cost control programs with metrics to report project
- Must be current and proficient in; newly introduced global concepts, practices, and procedures within the regulated life sciences with a core expertise regarding the practical design and implementataion fo ICH Q10
- The ability to lead a team of direct SME reports within a project
- Produce communications tools for reporting project progress and project completion reports
- Develop and Perform training for employees, contractor and clients
- Identifies opportunities to optimize client’s process technologies and improve quality
- Direct the design and scale-up of Quality Management Systems for pharmaceutical, biotech and Med Device manufacturing processes
- Able to provide QMS systems direction and expertise for compliance remediation projects including 483 citations, Warning letters and Consent Decrees
- Able to perform data collection and analysis to support new and ongoing quality metrics systems
- Have broad technical expertise to be able to select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up
- Working knowledge and challenges associated with new and emerging therapeutic technologies as they relate to quality and compliance requirements including gene sequencing, CRISPRS-Cas9, Antibody-Drug Conjugates (ADCs), stem cell, cellular/gene therapy, personalized medicine (CAR-T/TCR) and mRNA therapeutics
- Participate in the development and refinement of the Compliance sphere’s communication platform , collateral and website content
- Actively create white papers and write for trade journals on salient key principles in the compliance field
- Participate in trade shows as required to promote Pharmatech’s Sales and Marketing activities
- Participate in regular leadership management meetings in Hayward CA.
- Utilize industry network to grow Compliance sphere on a global bases.
- Support global implementation of projects as required.
MANAGERIAL RESPONSIBILITIES: Client management along with project specific management responsibilities
EDUCATIONAL REQUIREMENTS: Bachelor of Science, Chemistry or Bio-Medical Engineering preferred, or a Bachelor of Science in a related life science field
EXPERIENCE REQUIREMENTS: Minimum 15 years+ of experience in creating, managing and administering a Quality Management System for FDA regulated products is required. 5 years of formal and direct client management/responsibility in a consulting role is highly desirable.
REQUIRED TECHNICAL SKILLS / QUALIFICATIONS:
Candidates must be capable of applying diversified knowledge of compliance, regulatory and technical principles and have the ability to prepare compliance related technical documents for regulatory filings or product launches. Must be proficient with GDP, cGMP’s, GLPs, ICH, CFR and global regulations as appropriate. Familiarity with Minitab 18 or greater or JMP 13 is a plus.
Candidate must be highly experienced in performing a wide range of quality management systems formulation, process development and validation of multiple pharmaceutical dosage forms and must possess the following attributes:
- Strong written and oral communications
- Polished and accomplished presenter
- Strong project management skills
- Excellent technical writing skills
- Thrives and seeks out mission critical complexity and timelines
Essential knowledge of DOE, QRM and QbD frameworks:
- Risk Management Tools such as xFMEA’s and Hazard Analysis’s
- Quality Target Product Profile
- Critical Quality Attributes
- Critical Process Parameters
- Sampling theory for all aspects of development, production and release
- Basic Understanding of Statistical analysis ofprocess
- Excellent understanding ofprocessdesignandoptimizationprinciples
- Chemistry – Manufacturing – Control
- Root cause analysis methodologies
- Strong understanding of current FDA trends and requirements
- Experience intercting with FDA in PAI and surveillance audits, Type C meetings and telecons
- FDA relationships a plus
- Practical understanding of ICH best practices
- Active in industry professional societies such as PDA, ISPE, AAPS, DIA, RAPS and BIO
- Held leadership and/or commitee positions in local or national professional societies and chapters
PERSONAL TRAITS: Must be motivated, possess strong leadership skills, have the ability to work independently and/or function in a team environment. Enjoys complex challenges and working as part of high performing teams in developing leading edge industry compliance solutions.
ESSENTIAL JOB REQUIREMENTS: Travel to and work remotely at client sites throughout the United States and internationally. Exceptional professionalism and interpersonal skills. Adeptness to quickly gain client confidence and trust. Outstanding oral and written English communication. Advanced skills in Microsoft Office products, including Microsoft Project or an equivalent project management software. Comfortable with technology and using software tools such as WebEx, GoTOMeeting, Skype, and Cloud based data repositories. Ability to lift minimum 30 pounds and sit for extended periods of time.
PHYSICAL REQUIREMENTS: See Essential Job Requirements
TRAVEL REQUIREMENTS: On average travel should not exceed 25-30%.
REPORTS TO: Vice President, Compliance