Manager, Quality & Pharmaceutical Affairs

BIOCODEX•BIOCODEX USA, NJ

8d•$90,000 - $120,000•Hybrid

About The Position

The Manager, Quality & Pharmaceutical Affairs (MQPA) position will support the Quality and Regulatory Compliance of existing commercialized product portfolios: Dietary Supplements, as well as future products developed in the US. The MQPA will ensure that all quality aspects of commercial dietary supplement ingredient/drug substance/drug product manufacturing and release (including imported products/ingredients) at contract manufacturers/repacking, testing labs, and third party logistics warehouses, meet compliance requirements. In addition, this person will manage retailer requirements/standards and compliance programs (e.g. Amazon, CVS), vendor quality management, and provide backup support for adverse event reporting intake, medical triage, and tracking of AEs and product complaints as the Deputy Local Safety Officer. The MQPA will also shape the quality strategy to ensure adherence to regulatory standards. This position reports to the Head of Pharmaceutical Affairs, North America.

Requirements

10+ years of experience in quality and/or compliance within the pharmaceutical industry.
FSPCA certification in Preventive Controls for Human Food (PCQI).
Extensive experience in the US and Canada Market, with a focus on FDA and Health Canada regulations.
In-depth knowledge of pharmaceutical quality systems, development, manufacturing, testing (including stability), and validation.
Familiarity with relevant regulations and guidelines, including 21 CFR 210/211 and ICH Quality Guidelines.
Strong communication skills, both written and verbal, with the ability to effectively present information to diverse audiences.
Attention to detail, accuracy, and commitment to producing high-quality work.
Demonstrated ability to write clear and concise documents
Bachelor's Degree in Chemistry, Biology, Engineering, or a related field

Nice To Haves

ASQ certification preferred: Certified Quality Auditor (CQA), and or Certified Pharmaceutical GMP Professional (CPGP).
A reliable team-player with strong organizational, project management, detail oriented, and communication skills.
Proactive work style.
Ability to be resilient, flex, and adapt to internal and external change.
Work collaboratively across the organizations.
Autonomous and ability to work in fast-changing and multi-tasking environment.
Ability to manage and communicate in a scientific and medical environment.
Strong management and leadership capabilities
Excellent writing skills.

Responsibilities

Collaborating with the Head of Pharmaceutical Affairs to establish and implement Quality and Regulatory Compliance short and long-term objectives.
Championing a Culture of Regulatory and Quality compliance throughout the organization and leading continuous improvement efforts.
Serving as the quality expert on cross-functional teams, providing guidance on quality and compliance matters, such as supporting R&D development activities by providing validation and tech transfer guidance.
Support the assessment, coordination, preparation, and submittal of regulatory submissions to meet requirements (i.e. Gluten Free, NSF GMP certification, and non-GMO).
Oversee the Inspection, testing and release of all drug, dietary supplements, and natural health products.
Manage the review and approval of all product packaging and labels, commercial and medical materials, and all other support collateral reviewed by the Promotional Review and Medical Review Committees.
Maintain and manage electronic repositories for all document retention.
Conducting internal audits, supplier audits, and regulatory inspections as required.
Work directly with operating entities (internal and CMOs/ Testing Labs/3PLs) to ensure products meet all required quality standards, specifications and on-going performance is monitored and maintained. In addition, ensure that operations adhere to CGMPs and regulatory requirements of FDA, Health Canada, and other regulatory agencies, as required.
Product Releases- oversee receiving, traceability, and release activities (3PLs, repackers), manage nonconformances, quarantine, discrepancies, and maintain retains program and sample traceability
Review and approve Production Records, Specifications, Test Methods, Validation and Stability Protocols and associated reports.
Facilitate resolution of quality issues in a timely manner.
Overseeing contract manufacturing organizations and representing QA during manufacturing campaigns.
Reviewing batch records, test data, and issuing Certificates of Analysis.
Change Control & Product Lifecycle Management of formulations, packaging, supplier, and process changes.
Collaborating with stakeholders on deviation investigations, CAPA plans, root cause analysis effectiveness checks, trending, and escalations.
Support Pharmacovigilance AE reporting as backup to adverse event intake, medical triage, and tracking of AEs & product complaints.
Cross-functional collaboration for creation and support of quality SOP’s.