VP, Quality Assurance, GcP

COMPANY DESCRIPTION

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW: 

The VP, Quality Assurance, GcP will guide and motivate teams, overseeing project ownership and financial management, fostering a unified organizational culture, contributing the business growth, ensuring quality, and aiming for industry leadership.  

WORK LOCATION: 

The VP, Quality Assurance, GcP position is eligible for remote work based on company requirements, with no minimum in-office requirement; however, domestic and international travel is required for this position (up to 20%).   

JOB FUNCTIONS: 

(This list is not exhaustive and may be supplemented and changed as necessary.) 

• Lead and inspire teams, oversee project ownership of large-scale projects, and provide sales support while fostering the development of team members. 

• Manage staffing and hiring processes, allocate resources effectively, and assume financial responsibility for clients within the pod. 

• Cultivate a unified organizational culture across teams. 

• Develop and mentor team members, contribute to business development efforts, and ensure project quality across all functions. 

• Strive to become a thought leader in the industry. 

• Serving as Head of Quality within client organizations and collaborate closely with clients to understand their unique challenges and goals related to clinical quality management. Develop, enhance, and implement clinical and nonclinical QA functions and quality systems in accordance with ICH Guideline E6 (R2) (GCPs), 21 CFR part 58 (GLP), and other global regulatory authority requirements, and industry practices. 

• Quality Management Systems: Conduct comprehensive assessments of clients' existing quality management systems, policies, and procedures as it relates to clinical quality. 

• Strategic Guidance: Develop and implement tailored strategies and recommendations to improve clinical quality and compliance with industry regulations. 

• Training and Education: Provide training sessions and educational materials to Syner-G Biopharma and client staff to enhance their understanding of clinical quality management principles. 

• Performance Metrics: Define and establish key quality performance metrics and KPIs for clients to monitor and measure their progress. 
• Quality Issue and Risk Mitigation: Identify potential risks and compliance issues within clients' clinical operations and develop risk mitigation plans. Collaborate and provide QA expertise in processes such as investigations, CAPA plans, trial protocol deviations, complaints, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review. 

Client Vendor Qualifications, Auditing, and Monitoring including: 

• Developing and implementing an early-stage clinical and nonclinical site quality audit programs in collaboration with study teams 

• Designing and executing risk-based audit plans/schedules in collaboration with clinical and nonclinical study teams, including establishment of appropriate quality compliance criteria, to assure compliance with regulations, guidelines, and standards. 

• Conducting qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts. 

• Conducting internal audits to assess effectiveness of GCP/GCLP/GLP QMS and process compliance including Clinical Study Report and Trial Master File audits 

• Drafting audit plans, audit reports, audit observations, overseeing audit response process and drive audits to closure. 

• Evaluating audit observation trends and compliance risks, escalate to QA Management, as required.                                                                                                                 

OTHER FUNCTIONS: 

(This list is not exhaustive and may be supplemented and changed as necessary.) 

• Support internal quality initiatives, such as consultant training and QMS management. 

Inspection Readiness: 

• Inspection readiness by strategizing, collaborating, executing, etc. plans/tasks to prepare and support impacted programs/study teams. 

• Ensuring the clinical and nonclinical sites are audit ready and compliant at all times. 

• Participating during regulatory agency inspections                                                                                                                             

QUALIFICATIONS AND REQUIREMENTS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. 

Education: 

• A bachelor’s or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required. 

Technical Experience: 

• 15 plus years of relevant experience in IND/NDA/BLA pharmaceutical product development. 

• Extensive experience in clinical quality management systems within healthcare organizations. 

• Proven track record of successfully implementing quality improvement initiatives. 

• Exposure to CRO development and development teams. 

• Demonstrated experience with both small and large molecules. 

• Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required. 

• Demonstrated experience performing GCP/GLP auditing of clinical facilities. 

• Working knowledge of cGxPs, ICH, and applicable international regulations and guidelines. 

• Ability to evaluate and follow-up on quality events, incidents and possible complaints. 

• Understanding of quality system reviews, deviations, OOS, CAPAs, and other remediation plans depending on client needs. 

• Comprehensive understanding of applicable CFR regulations, GCP guidelines, clinical quality standards, ICH guidelines, quality management systems initiatives, and industry-specific regulations. 

• Understanding of computers systems validation methodologies and related industry expectations. 

• Ability to support the development, implementation, and maintenance of client quality systems including facilitating process improvement activities to the product and project teams. 

• Adept at applying risk-based and phase-appropriate quality approaches. 

Knowledge, Skills, and Abilities:

• Proven leadership experience in managing teams, projects, and client relationships within a pharmaceutical or biotech environment. 

• Strong communication skills, with the ability to mentor, educate, and influence a diverse group of stakeholders. 

• Ability to work in a fast-paced, dynamic environment, managing multiple projects and clients while ensuring alignment with business goals. 

• Business acumen, with a focus on business development, marketing, sales support, and client engagement. 

• Strong leadership and people management skills, fostering collaboration, consensus-building, and team development. 

• Strong Quality Management System knowledge and skills.  

• Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.  

• Excellent project management skills to effectively organize, prioritize, and plan client deliverables. 

• Effective relationship-building and client management skills, alongside confidence in decision-making and trust-building.  

• Ability to be adaptable, flexible and develop creative approaches to meet customer needs and improve customer outcomes. 

• Exceptional stakeholder management skills with the ability to adapt influencing strategies, articulate compelling solutions, uncover client concerns through insightful questioning, and address objections effectively  

• Ability to work independently with minimal supervision and problem solve proactively.  

• Skilled communicator, both written and verbal, who can present ideas and critical information to clients and internal team members effectively and in a concise, organized, impactful manner. 

• Strong organizational skills and attention to detail.  

• Strong critical thinking and problem-solving skills: ability to exercise sound reasoning to analyze issues, make decisions, and overcome problems.   
• Ability to work effectively within a team environment by encouraging collaboration and exhibiting an interpersonal style that is enthusiastic, approachable, and supportive.                                                                                                                                                         

ESSENTIAL FUNCTIONS:  

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.