The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing, and Controls
(CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
Syner-G Pharma Consulting is seeking a talented Director/Senior Director of Quality Assurance in CMC Compliance with 10 to 15 years’ experience working in Quality Assurance in a Biotech or Pharmaceutical FDA regulated industry. The Quality Director will be able to work independently and help lead the Quality Assurance business vertical by being the face of the service organization for Syner-G and our clients. The Director of Quality is responsible for collaborating with other business verticals such as CMC and regulatory to achieve client needs when appropriate. The dynamic Quality Assurance Director will review and approve SOPs, product specifications, batch records, and Annual Product Quality Reports for authoring, reviewing, and facilitating the timely completion of regulatory documents to approval. The ideal candidate will have experience in Quality System Development, CMC conformance, Gap Analysis, and Remediation, together with a solid knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and ROW.
- Build and implement Quality systems for clients based on client business needs.
- Conduct Quality audits for development and commercial products.
- Responsible for batch disposition of clinical products, including drug substances, drug products, and finished products.
- Independently lead multiple client projects in Quality and Compliance.
- Act as subject matter expert on quality issues for small molecules (different dosage forms) and work with clients to resolve Quality and compliance-related matters for manufacturing, packaging, and distribution.
- Lead a team of Senior Quality consultants to achieve goals on different Quality projects.
- Author and review procedures, specifications, quality reports, and other quality documents, customized to different client business processes and requirements.
- Provide leadership, advice, and direction to clients and Quality consultants, consistent with GxP.
- Master’s degree in life sciences or a technical discipline; advanced degree in Chemistry, Biology or equivalent preferred.
- 15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product development, manufacture, and quality.
- 8+ years of Quality management experience.
- Excellent team-building, leadership, and management skills.
- Minimum 10 years’ experience with small molecule and different dosage forms.
- Minimum of 15 years of cGMPs, ICH, and applicable international regulations and guidelines.
- Solid knowledge of global regulations and standards.
- Strong team player that has a customer service approach and is solution-oriented.
- Strong understanding of phase appropriate cGMP requirements.
- Excellent written, verbal, and interpersonal skills.
- Experience managing health authority pre-approval inspections and routine audits.
- Experience managing quality and compliance remediation projects.
- Strong attention to detail and the ability to independently prioritize and multitask.
- Knowledge of drug development lifecycle and applied a comprehensive understanding of regulations and guidelines to enhance the probability of regulatory success and regulatory compliance required.
- Experience performing GMP auditing of manufacturing facilities of clients, vendors, and internal operations.
- Ability to Support development, implementation, and maintenance of the Client’s Quality System, including, facilitating process improvement activities to the product and project teams for continuous improvement.