Senior Manager QA and Compliance - Simply Biotech - TalentZok
San Diego, CA
About the Job
Senior Manager- QA and Compliance- Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for an Senior Manager - QA and Compliance with a biotech company in San Diego, CA who possesses:
- Bachelor's degree in a scientific or related field; Master's Degree highly preferred
- 8+ years of experience in quality assurance, regulatory affairs, compliance roles, and EHS program management within the pharmaceutical or biotechnology industry
- Expert in FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA, and environmental health regulations.
- Must have experience with improving processes
Email resumes to kbrace@simplybiotech.com or call 858.683.8559
FULL DESCRIPTION: The Associate Director of Quality Assurance and Compliance is responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations. This leadership position requires extensive experience in quality assurance, regulatory affairs, compliance management, and EHS oversight within the pharmaceutical or biotechnology industry. The role oversees the development, implementation, and maintenance of quality systems to uphold regulatory standards and supports the company's commitment to scientific integrity, excellence, and speed of service, with a specific emphasis on FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA compliance, and EHS management.
The selected candidate will be responsible for:
- Develop and implement strategic plans for quality assurance, compliance, and safety initiatives, including EHS oversight, in alignment with organizational goals and regulatory requirements such as FDA (GLP), USDA, AAALAC, OLAW, DEA, and OSHA regulations.
- Serve as the company's Safety Officer, providing leadership in the development, implementation, and management of safety programs, including the Injury and Illness Prevention Program (IIPP) and other EHS-related programs.
- Oversee the Safety Committee and EHS functions, ensuring effective identification and mitigation of workplace hazards and environmental health and safety compliance.
- Provide leadership and direction to the Quality Assurance, Compliance, and EHS teams, fostering a culture of excellence, accountability, continuous improvement, and strict adherence to Standard Operating Procedures (SOPs).
- Collaborate with senior management to establish quality, safety, and EHS objectives, metrics, and performance indicators to drive operational excellence.
- Oversee the development, implementation, and maintenance of robust quality, safety, and EHS systems, including Document Control, Training, Change Control, Deviation Management, CAPA (Corrective and Preventive Actions), and OSHA compliance.
- Ensure compliance with applicable regulatory requirements, including FDA, USDA, AAALAC, OLAW, DEA, OSHA, and environmental health and safety regulations, as well as industry standards such as Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
- Manage the development, implementation, and ongoing review of the IIPP and other EHS programs to promote a safe and compliant work environment.
- Cultivate a culture of SOP adherence and enforce EHS policies and procedures, ensuring that they reflect current regulations, industry best practices, and company standards.
- Conduct regular audits, assessments, and EHS inspections to identify areas for improvement and ensure adherence to quality, safety, and environmental health standards and regulatory requirements.
- Lead inspections and audits by regulatory agencies, external auditors, and EHS inspections, ensuring timely responses and resolution of findings.
- Monitor and maintain Standard Operating Procedures (SOPs), safety, and EHS protocols, ensuring their effectiveness, relevance, and compliance with regulatory and safety standards.
- Monitor changes in regulatory requirements, including FDA, USDA, AAALAC, OLAW, DEA, OSHA, and EHS regulations, assessing their impact on the organization and implementing necessary changes to maintain compliance.
- Develop and maintain policies, procedures, and guidelines to ensure compliance with regulatory standards, industry best practices, and EHS standards, including OSHA regulations and environmental health protocols.
- Provide guidance and support to cross-functional teams on compliance, safety, and EHS-related matters, including interpretation and application of regulations, standards, and safety protocols.
- Oversee incident reporting, investigation processes, and EHS compliance, ensuring corrective actions are implemented to prevent recurrence and that OSHA and EHS logs are accurately maintained.
- Develop and deliver training programs on quality systems, regulatory requirements, compliance practices, safety procedures, and EHS protocols to ensure staff competency, awareness, and a culture of safety and environmental responsibility.
- Cultivate a culture of ongoing training and SOP adherence by ensuring all employees understand and follow SOPs related to their roles, including EHS guidelines.
- Provide coaching and mentorship to staff within the Quality Assurance, Compliance, and EHS departments, fostering professional growth and development.
The selected candidate will also possess:
- Expertise in FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA regulations, and EHS management.
- In-depth knowledge of safety regulations, EHS program management, and OSHA compliance, including experience with IIPP and environmental health and safety protocols.
- Flexibility, self-starting, and self-management.
- Quick turn-around on requests, with accuracy and thoroughness being critical.
- Strong organizational and analytical skills.
- Strong knowledge of animal welfare regulations, vivarium management, and animal care standards.
- Knowledge of good documentation practices.
- Knowledge of Animal Care and Use Protocol (ACUP).
- Proficiency in Microsoft Office Suite, including Word, Excel, Outlook, and general working knowledge of the internet for business use.
- Ability to handle multiple tasks, respond quickly and efficiently, and keep situations under control in a fast-paced, dynamic work environment.
- Ability to keep abreast of the latest technology in relation to the position.
- Ability to follow all applicable laws, rules, regulations, and company policies and procedures.
- Ability to work harmoniously as a member of a team and independently once provided training and instructions.
- Ability to adapt to changing procedures, policies, and work environments.
- Ability to compose clear, concise, and professional written communication.
- Ability to meet deadlines and work under pressure.
- Flexibility and adaptability with workload, shifting priorities as needed.
- Ability to demonstrate cross-cultural sensitivity.
- Demonstrate honesty and integrity through open, honest, and trustworthy communication.
- Maintain safety and study quality standards.
- Perform tasks for experiments following step-by-step protocols.
- Maintain positive interactions with co-workers.
- Ability to work occasional weekend, early morning, or late-night shifts as required.
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- 8+ years of experience in quality assurance, regulatory affairs, compliance roles, and EHS program management within the pharmaceutical or biotechnology industry, including expertise in FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA, and environmental health regulations.
- Demonstrated experience in cultivating a culture of inspection readiness, SOP adherence and providing comprehensive training programs.
- Demonstrated experience in leading quality management systems, regulatory inspections, compliance programs, safety programs, EHS management, and SOP monitoring and maintenance.
Salary Range: $150k-$160k/yr
For immediate and confidential consideration, please email your resume to kbrace@simplybiotech.com or call 858.683.8559. More information can be found at www.simplybiotech.com
Source : TalentZok
