Job Description

Job Description

Job Description

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.

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POSITION OVERVIEW:

The Senior Consultant, Quality leads the evaluation of quality events, incidents, and possible complaints and the follow-up of such events. Perform / Lead GMP auditing of manufacturing facilities of clients, vendors, and internal operations as well as ensure that the CMC Quality vertical works seamlessly with Syner-G's Technical group, Regulatory Affairs, CMC leads, and others on the team, as well as key external parties. The Sr Consultant will operate independently, managing day-to-day operations with minimal input or support needed.

WORK LOCATION:

This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 25%).

JOB FUNCTIONS:

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

• Work individually and lead others in the Quality business vertical by being the face of the service for Syner-G and our clients.
• Collaborate with other business verticals like manufacturing and CMC Technical and Regulatory teams to achieve client needs when appropriate.
• Review and approve SOPs, product specifications, batch records, and Annual Product Quality Reports.
• Lead / 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.
• Lead / Support Quality System reviews, deviations, OOS, CAPAs, and other remediation plans depending on client needs.
• Review the source batch records, COAs, Stability data, and regulatory documentation for the products.
• Manage pre-approval inspections by health authorities and internal audits.
• Lead / Support building the quality vertical for Syner-G.
• Serve as a subject matter expert in areas such as facility cleanroom design, offering guidance and recommendations based on extensive experience.
• Act as a liaison between clients and CMOs/Contract labs.
• Approve all documents before clinical trials, including creating Certificates of Analysis (COAs) for drug release, expanding accounts from the original Statement of Work (SOW), and providing project components to regulatory bodies such as the FDA.
• Possess proficiency in influencing others to achieve objectives, strong problem-solving and critical thinking abilities, comprehensive understanding of all phases of drug development from analytical to manufacturing to commercial, and confidence in leading clients in decision-making processes.

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 accommodation 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 :

• 2-5+ years FDA field inspection experience.
• 10+ years of relevant experience in pharmaceutical industry.
• Field inspection experience of small and large molecule pharmaceutical/ biotech companies.
• Perform cGMP inspections of finished drug facilities, API manufacturers, contract laboratories.
• Conduct Pre-Approval Inspections (PAI) of laboratory facilities.
• Familiar with FDA/ORA Investigator practices and procedures.
• Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required.
• 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, Regulatory guidelines, 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 :

• 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.
• Demonstrated leadership and management skills.
• 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:

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; Boulder, CO; and Chennai, India.

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.

Job Tags

Holiday work, Contract work, Remote job, Flexible hours,

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