Title: QC Head

Date: Aug 13, 2025

Location: Sun - Billerica - Plant

Company: Sun Pharmaceutical Industries, Inc (USA)

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures.

Area of Responsibility:

Execute and review analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, ISO Quality Assurance Procedures, SOPs and established deadlines

Establish and maintain a comprehensive QC training program for analytical personnel and reinforce the training with appropriate assignment(s) and delegation of responsibility

Monitor and prepare formal evaluations of employee performance to ensure continued compliance

Ensure safe operations in the laboratory

Coordinate transfer of methods (new/alternate, customer supplied (ILQ) or improved methods) or technology (instruments) into the QC laboratory

Train QC analysts on new/improved instruments and test methods

Identify, procure, install and qualify required QC instrumentation and equipment

Establish and maintain laboratory programs to monitor and evaluate systems or equipment (i.e. analytical instrument and equipment, etc.) status, ensure efficient laboratory performance and compliance with preventive maintenance, qualification, and calibration schedules

Establish and maintain laboratory programs to process, monitor and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput

Oversee and allocate personnel required to ensure deadlines are met

Direct and close all QC Stage 1 OOS investigations, deviations, CAPA, and QA investigations within established target dates

Oversee and continuous improvement of FDA compliant Quality System

Manage the team including mentoring and coaching of staff, establishing priorities, and delivering projects within budget and on time

Use a team-oriented approach to problem resolution

Other duties as assigned

Work Conditions:

Office

Lab

Controlled area/clean room

Exposure to noise, heat, open flame and radiation in certain areas

Exposure to non-hazardous and hazardous chemicals, toxic metals (arsenic, lead, and mercury)

Cryogenic gases (LN 2) and radioactive materials

Requires access/work in chemical fume hoods

Exposure to/use of syringes and needles

Experience:

Minimum 6-8 years related experience with minimum 0-2 years related experience in a supervisory role preferred

Comprehensive knowledge of wet chemical and instrumental analysis methods, including method development and validation

Proficient verbal, written and interpersonal communication skills

Excellent supervisory skills

Ability to work with minimal supervision

Strong chemistry theory skills

Strong organization skills

Position requires a balance between administrative (office) duties and laboratory work

Understanding of cGMP, GLPs and ISO requirements

Computer literacy/proficiency; PC with spreadsheet and or instrument control software

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.