Director, Quality Compliance
Description Tris Pharma, Inc. is a leading privately-owned biopharmaceutical companies in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of over innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. Our Quality department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Director, Quality Compliance. The Director, Quality Compliance provides quality compliance leadership and support to the total Quality function to ensure continuous compliance with Standard Operating Procedures (SOPs), global current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards, relevant foreign drug regulatory standards, established specifications, and drug registrations. The incumbent has direct oversight of Quality Compliance department activities, development of its personnel, and ensuring the quality of deliverables within her/his purview. She/he is recognized as subject matter expert in the principles and applications of quality compliance and serves as a decision maker and point of escalation for customer, internal, external, and customer quality compliance concerns/issues. Additionally, the incumbent is responsible for leading the quality oversight of R&D activities. ESSENTIAL FUNCTIONS o Leads the total Quality Compliance function for the manufacturing, testing, warehousing, and R&D facilities. Ensuring adherence to, and compliance with, all SOPs, cGMPs, FDA standards, Drug Enforcement Agency (DEA) requirements, and applicable international drug enforcement agency regulations, as well as all applicable company quality compliance guidelines, standards and objectives. o Promotes a strong quality culture mindset throughout the organization. Leads by example, fosters a trusting and collaborative work environment, focused on execution and delivering results, thinks critically, and has the ability to assess the risks and make a quality compliance decision. o Presides over the company's supplier qualification program to systematically evaluate the company's suppliers based on:
the risk to the quality of the product or service supplied, quality and compliance history of the supplier, compliance of the supplier's quality systems to applicable regulations and requirements of the supply contract or quality agreement, and the reliability of the supplier including periodically assessing audit reports and/or audit questionnaires, evaluating the quality of the product or service supplied based on analytical data and historical results, obtaining and maintaining quality agreements with the suppliers. o Heads the Quality Assurance function with the company's External Partners. Ensure contract manufacturers, packagers/re-packagers, distributors, laboratories adhere to compliance with cGMP, FDA, Drug Enforcement Agency (DEA), Occupational Health and Safety Administration (OSHA) regulations, and approved Quality Agreements, as well as applicable company compliance guidelines, standards and objectives. This includes providing the Quality Assurance support for those partnerships in which Tris acts as the contract manufacturer, packager/re-packager, laboratory, or distributor, including private label distributor partnerships. o Oversees the overall QA function for R&D to ensure compliance of R&D activities with appropriate cGMP, GLP, and data integrity requirements. This includes overseeing the review, approval, and release of clinical, pivotal, and submission batches and their related analytical data. This also includes overseeing the review and approval of method validation protocols and summary reports. o Hosts drug regulatory inspections and customer audits; Provides information as necessary to FDA and other national drug regulatory authorities that establishes credibility and demonstrates compliance with cGMPs; Coordinates with drug regulatory agencies and other external auditors to build trust and confidence in the site's quality systems; Promotes and advances quality awareness throughout the company; Ensures inspection readiness of the site. Responsible for responding to audit findings and communicating with the Regulators and customers as to the status of any remedial activities required to address audit findings. o Responsible for GMP communications with the regulatory agencies including the reporting requirements such as US FDA Field Alert Report (FAR) regulations:
21 CFR 314.81 & 21 CFR 314.98 o Runs internal audit program for the company's Monmouth Junction and Cranbury, NJ facilities o Presides over the GMP intelligence program to ensure that cGMP news, trends, and/or regulatory changes that may impact the company are communicated, assessed, and have action plans developed and implemented to ensure ongoing quality compliance of the company o Develops, compiles and analyzes business metrics and highlights for the Quality Compliance function o Manages, mentors, coaches, and develops direct reports and the entire Quality Compliance organization Requirements Requirements Bachelor's degree in a Science or related field AND a minimum 8 years of experience in the pharmaceutical or biotechnology industry in quality or compliance positions of increasing technical and leadership responsibility REQUIRED o Expert knowledge of cGMPs in the US REQUIRED. Strong knowledge of international pharmaceutical cGMPS PLUS o Experience with both internal and external cGMP auditing REQUIRED o Proven track record of successful interactions with the FDA and other health authorities REQUIRED o Experience with supplier qualification and quality assurance for external partnerships REQUIRED o Proven people management experience REQUIRED o Ability to influence without direct authority REQUIRED Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
Salary Range:
$150K -- $200K
Minimum Qualification
Auditing & Compliance, Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
the risk to the quality of the product or service supplied, quality and compliance history of the supplier, compliance of the supplier's quality systems to applicable regulations and requirements of the supply contract or quality agreement, and the reliability of the supplier including periodically assessing audit reports and/or audit questionnaires, evaluating the quality of the product or service supplied based on analytical data and historical results, obtaining and maintaining quality agreements with the suppliers. o Heads the Quality Assurance function with the company's External Partners. Ensure contract manufacturers, packagers/re-packagers, distributors, laboratories adhere to compliance with cGMP, FDA, Drug Enforcement Agency (DEA), Occupational Health and Safety Administration (OSHA) regulations, and approved Quality Agreements, as well as applicable company compliance guidelines, standards and objectives. This includes providing the Quality Assurance support for those partnerships in which Tris acts as the contract manufacturer, packager/re-packager, laboratory, or distributor, including private label distributor partnerships. o Oversees the overall QA function for R&D to ensure compliance of R&D activities with appropriate cGMP, GLP, and data integrity requirements. This includes overseeing the review, approval, and release of clinical, pivotal, and submission batches and their related analytical data. This also includes overseeing the review and approval of method validation protocols and summary reports. o Hosts drug regulatory inspections and customer audits; Provides information as necessary to FDA and other national drug regulatory authorities that establishes credibility and demonstrates compliance with cGMPs; Coordinates with drug regulatory agencies and other external auditors to build trust and confidence in the site's quality systems; Promotes and advances quality awareness throughout the company; Ensures inspection readiness of the site. Responsible for responding to audit findings and communicating with the Regulators and customers as to the status of any remedial activities required to address audit findings. o Responsible for GMP communications with the regulatory agencies including the reporting requirements such as US FDA Field Alert Report (FAR) regulations:
21 CFR 314.81 & 21 CFR 314.98 o Runs internal audit program for the company's Monmouth Junction and Cranbury, NJ facilities o Presides over the GMP intelligence program to ensure that cGMP news, trends, and/or regulatory changes that may impact the company are communicated, assessed, and have action plans developed and implemented to ensure ongoing quality compliance of the company o Develops, compiles and analyzes business metrics and highlights for the Quality Compliance function o Manages, mentors, coaches, and develops direct reports and the entire Quality Compliance organization Requirements Requirements Bachelor's degree in a Science or related field AND a minimum 8 years of experience in the pharmaceutical or biotechnology industry in quality or compliance positions of increasing technical and leadership responsibility REQUIRED o Expert knowledge of cGMPs in the US REQUIRED. Strong knowledge of international pharmaceutical cGMPS PLUS o Experience with both internal and external cGMP auditing REQUIRED o Proven track record of successful interactions with the FDA and other health authorities REQUIRED o Experience with supplier qualification and quality assurance for external partnerships REQUIRED o Proven people management experience REQUIRED o Ability to influence without direct authority REQUIRED Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
Salary Range:
$150K -- $200K
Minimum Qualification
Auditing & Compliance, Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
